Luer Receiver and Method for Fluid Transfer

ABSTRACT

An improved luer lock receiving septum having a configuration which provides rapid and tight resealing and yet allows penetration of the septum by the luer tip with a low penetration force. The elongated septum includes an upper portion of enlarged diameter having a target surface, a central slit, and a central, lower septum extension projecting about the slit below the upper portion and into a housing so that following luer insertion there is provided sufficient room for both the laterally displaced extension of the septum, the luer taper, and the housing to be received into a conventional luer lock connector. The septum is further preferably configured to minimize or eliminate the negative pressure deflection normally associated with the withdrawal of the large diameter luer cannula from an enclosed fluid filled lumen or chamber, by substantially isolating the lumen or chamber from the septum material displacement resultant from luer insertion. In an exemplary embodiment, the luer receiving septum is provided at a port of a stop cock.

This application is a continuation of U.S. patent application Ser. No.11/350,059, filed Feb. 9, 2006, which is a continuation of Ser. No.09/635,153 (now U.S. Pat. No. 7,033,339), filed Aug. 8, 2000, which is acontinuation-in-part of U.S. patent application Ser. No. 09/322,037 (nowU.S. Pat. No. 6,171,287), filed May 28, 1999, which claims the benefitof U.S. Provisional Application Ser. No. 60/087,162, filed May 29, 1998,and U.S. Provisional Application Ser. No. 60/101,998, filed Sep. 28,1998, the entire disclosures of all five of which are incorporatedherein by this reference.

BACKGROUND AND SUMMARY OF THE INVENTION

This invention relates to luer access devices for the engagement ofconventional luer lock connectors and particularly to systems usingpenetration of a luer tip of a luer lock connector into a septum toachieve access for medical fluid transfer.

The high cost of the nascent “needle free” medical fluid access systemsis well known. Much of this cost is related to the widespread use ofcannulae for penetration of septa or to the use of expensive lueractivation valves and internal spike based systems.

The ideal medical fluid access device must be applicable to all medicalfluid delivery or blood access systems including IV lines, saline wells,arterial lines, hemodialysis lines, and any other site wherein fluidaccess for blood withdrawal or drug and fluid injection is desired andmust have the following nine important characteristics:

-   -   1. Backward compatibility with conventional blunt cannulae.    -   2. Absence of flow limitation below the rate of flow through the        luer cannula.    -   3. Absence of substantive negative pressure upon withdrawal of        the luer lock connector from the device.    -   4. Low force of insertion of the luer tip into the device.    -   5. Absence of substantive kickback after luer tip slip insertion        so that a luer tip will remain in a resting advanced position        after insertion.    -   6. Small footprint and low profile (as is associated with        conventional simple reseals).    -   7. Isolation of fluid flow to the central flow path within the        device.    -   8. The basic design must provide a configuration which can be        deployed without fluid dead-space in connection with the fluid        interface. (Dead-space, such as that associated with the fixed        lumen of central spike, will leave residual blood in the device        if it is used for blood withdrawal).    -   9. Manufacturing cost similar to conventional standard reseals.        (These simple devices were the basic access sites for fluid        access for over 2 decades and constitute the cost basis for the        optimal target manufacturing cost of any new system which        aspires to become the new universal standard.)

It is an object of the present invention to provide a medical fluidaccess device, which can provide all of these nine characteristics andwhich can become the new universal standard for medical fluid access.

U.S. Pat. No. 5,466,219 (the disclosure of which is incorporated byreference as if completely disclosed herein) provides background for thepresent invention and discloses a septum with a central slit having alow penetration resistance adjacent an upper septum portion and tightsealing adjacent a lower septum portion. This type of septum designallows penetration by a large diameter cannula, such as a luer tip, tobe achieved with an acceptable penetration force at the atmosphericinterface while providing tight sealing in a lower portion of theseptum. U.S. Pat. No. 5,474,544 (the disclosure of which is incorporatedby reference as if completely disclosed herein) also provides backgroundfor the present invention and discloses a luer penetration receivingseptum which eliminates the need for cannulae and needles. Thisinvention discloses an elongated solid septum with a central slit. Theseptum includes a solid centrally slitted portion projecting centrallywithin the housing. This portion has a reduced transverse dimensionlateral to the long transverse axis of the slit which effectivelyreduces the lateral deflection diameter of the septum after a luer tiphas been received into a central slit so that the septum and housing andthe penetrating luer taper can be contained within the confines of acylindrical luer lock connector. The preferred embodiment includes slotsin alignment with the long transverse axis of the slit to receive aportion of the laterally displaced septum volume on penetration by theluer tip. The use of properly positioned slots allows the lower portionof the septum to have sufficient mass lateral to the slit to reliablyrebound to its resting shape thereby rapidly closing the slit when theluer tapered cannula has been withdrawn.

Referring to FIG. 18, there is schematically shown therein a structure2010 that corresponds to a mock-up prop device that was made for showingthe concept of the invention of U.S. Pat. No. 5,474,544. That device wasformed by drilling out lateral portions of the septum 2034 to definecavities 2068 for receiving displaced septum portion(s) resulting frominsertion of a male luer into the septum 2034. More particularly, toform a luer receiver having a septum with an extension of reduced width,a commercially available injection site for receiving a narrow bluntcannula was drilled out from each side with a thin circular grindingwheel oriented in parallel to the slit and coming in through the housing2012, perpendicular to the slit to form cavities 2068 for receivingdisplaced septum portions when a male luer is inserted into the septum2034. It is evident that to ensure a patent fluid passage to thepatient, in a commercial form the septum would be performed to have thedesired extension and the housing walls would not be drilled through,e.g. the cavities 2068 would be defined entirely by the reducedthickness of the septum extension 2040, or cutouts in the housing wallwould not extend entirely therethrough. In this structure, the septum2034 was fully received within the housing 2012 and cavities 2068 aredefined lateral to the septum extension 2040.

The present invention includes an improved septum and housingconfiguration which is inexpensive to manufacture and which providesfeatures increasing the rebound to the resting “closed slit” positionthereby reducing the potential for leakage when used in situations ofhigh pressure, such as arterial lines or hemodialysis lines. The presentinvention also provides a configuration which is associated with areduced penetration force requirement for penetration of the septum,even with a flat faced large diameter luer tip, and which reduces oreliminates the negative pressure associated with luer tip withdrawal.

Generally the luer penetration receiver comprises a housing having aninlet and an outlet. The housing includes a proximal portion sized to bereceived and threaded into the conventional cylindrical luer lock end.An elongated elastomeric septum defining a longitudinal axis is providedhaving a sealing portion within the housing. The septum includes atarget portion comprising an upper septum portion and a lower septumportion. The upper portion preferably projects above the housing anddefines an atmospheric face. The lower portion is positioned adjacentthe housing inlet. A slit extends through the septum from the sealingportion to the atmospheric face. The slit defines a longitudinal axisalong the longitudinal axis of the septum and a long transverse axisalong the transverse axis of the septum. The septum can include opposinglateral slits or grooves which separate the upper portion from the lowerportion. The septum can further include an extension which projectscentrally within the housing and has a reduced transverse widthperpendicular to the long transverse axis of the slit when compared tothe upper portion.

The septum preferably occludes the housing inlet. The upper portion ofthe septum preferably has a cross-sectional area greater than thecross-sectional area of the luer tip. The inlet is configured to provideopposing inlet wall platforms positioned below the upper septum portion.(The platforms can also extend around the septum to be circumferential).The septum upper portion preferably rests on the upper surface of theinlet wall platforms. At least a portion of the opposing platforms arepositioned below opposing lateral portions of the upper portion of theseptum lateral to and in relative alignment with the long transverseaxis of the slit. The platforms preferably include opposing projections,which project into the opposing slits in the lateral wall of the septum.The opposing projections within the opposing slits preferably haveupwardly sloping surfaces and the surface is highest adjacent thelateral edge of the septum to lever the opposing portions of the lateralseptum portions upwardly with the leverage force being directed towardand along the long transverse axis of the slit thereby providing rapidresealing of the slit upon withdrawal of the luer tip from the slit. Inassociation with the wedge effect of the sloping surfaces below theupper septum portion, the advancement of the tip against the centralportion of the septum face induces relative upward deflection of thelateral portions of the septum by tipping the lateral walls upward asthe central portion of the face deflects downward. In the preferredembodiment, the inlet wall platform is circumferential and extends froma low position of opposing wall troughs adjacent and perpendicular tothe ends of the central slit, to a high position defining opposing wallpeaks extending along an axis in relative alignment with the longtransverse axis of the slit. This septum and inlet configurationfacilitates penetration by the large diameter luer tip by allowingmodest central downward deflection while tipping opposing lateralportions of the face upward thereby inducing a “facial valley” withlaterally opposing upwardly sloping septum portions of the face alignedwith the central slit. This induced configuration focuses the insertionforce to wedge open the slit in opposing vectors perpendicular to theslit. Further, the upward deflection of the opposing lateral portions ofthe septum effectively reduces the lateral cross-sectional area of theupper septum portion at the atmospheric face thereby facilitatingcapture of the septum by the surrounding luer lock housing duringpenetration. Upon withdrawal of the luer tip, the leverage forcediscussed supra causes the slit at the atmospheric face to be forciblyclosed. An important and unexpected benefit of using focused leveredupward lateral deflection to seal the uppermost portion of the slit isthat this configuration places the seal in a mechanically receptiveposition to be easily penetrated by even a flat large diameter luer tip.In addition, this configuration allows the resting concavity at the faceto be minimized. If preferred, the upper portion of the septum can bemolded in a “mushroom” configuration with the lateral walls thereofsloping downward and the undersurfaces of those lateral walls slopeddownwardly, and the septum subsequently slit in this configuration. Withthis configuration upward deflection of the lateral walls can be inducedby lateral portions of the housing that are not elevated and in factcould have a horizontal or even slightly laterally downwardly slopingconfiguration provided the downward slope is less than the downwardslope of the undersurfaces of the lateral walls of the upper portion ofthe septum. This configuration will induce wedge compression at the slitadjacent the surface of the septum without a significant facial valley.

To provide additional sealing, the septum can have a region of focusedcompression of a short segment of the slit below and adjacent to theupper portion of the septum and preferably immediately adjacent theportion of the slit sealed by the leverage inducing platforms describedsupra. A second region of focused compression can be provided adjacentthe extension or adjacent a distal end of the septum. The septum caninclude a lower portion mounted between the opposing platformprojections which are aligned with the long transverse axis of the slitand which can project into the corresponding matching grooves in thelateral wall of the septum (which can be the same lateral grooves notedabove which separate the upper and lower housing portions). The septumhas a lateral transverse dimension intermediate the projections slightlygreater than the corresponding internal dimension intermediate theopposing projections between which the septum is positioned. The septumis thereby slightly compressed transversely along a short longitudinalsegment of the slit by the opposing projections perpendicular to theslit. This compression can be focused along a short segment of the slitby configuring the projections to have a narrow projecting verticaldimension at the projection ends such as is provided by a relativelypointed end. As described for the upper face, the upper surface of theplatform projections are sloped to facilitate vertical deflection orexpansion of the septum during insertion of the luer tip. This can alsobe provided for the lower surface of the projection. This is beneficialbecause the cylindrical luer lock connector is severely constrainingrelative to the potential space available for lateral deflection and anyvertically deflected volume (especially upward and away from the housinginlet) can reduce the width of the lateral space required. While thefocused compression induces resistance to penetration by the luer tip,this resistance can be easily overcome because of the matched shape ofthe projections and septum allows for expansion around (above and below)the projections into septum expansion receivers such as horizontalslots. A region of reduced resistance to the upwardly wedging forcealong the septum, such as is provided by extending the opposing lateralslits, intermediate the projections can be provided. The extendedlateral slits and the focused compression just below the point whereinthe central slit is levered closed allows the upper portion to be wedgedupward without pulling open the central slit below the wedge.

When the luer tip is pushed against a septum face with theaforementioned configuration, a facial valley develops, easy penetrationoccurs, and, upon penetration, the opposing upper portions of the septumlateral to the long transverse axis slit are displaced laterally. To beuseful as a luer lock receiver, it is very important to note thatdespite the receipt of the large diameter luer tip, the extent oflateral expansion of the septum must be contained within a minimal spaceso that the luer penetration receiver can be threaded into the limitedconfines of the cylindrical luer lock connector. This is true for boththe septum portion contained within the housing and any septum portionabove the housing. Also despite the tight space limitations and the needfor tight sealing of the slit, lateral expansion of the slit by the luertip must not be greatly inhibited so as to minimize the force of luertip penetration into the septum. In the present invention, the housingand the septum are configured to present to each other a reducedvertical cross-sectional surface area for compressive contact betweenthe housing and the septum during lateral septum expansion. This reducesthe magnitude of the penetration force required to achieve lateralexpansion of the septum thereby minimizing the penetration force. Usingnarrow opposing platform projections of the inlet wall can minimize thisvertical cross-sectional area and facilitate expansion into anassociated slot inferior or superior to the projection. By positioningthe housing inlet adjacent the upper portion of the septum and byeliminating or reducing any housing structure lateral to the outer wallof the septum upper portion, the functional equivalent of acircumferential slot is achieved for the septum upper portion, allowingease of lateral displacement of the septum upper portion above the inletplatforms. Alternatively, slots, or cutouts interposed between narrowvertically oriented posts may be used either lateral to the septum upperportion and/or lateral to the septum lower portion. This configurationallows much of the laterally expanded septum mass to be displaced around(above, below, or between) the posts rather than being compressedagainst it.

As noted previously, the septum further can include an extension havinga smaller cross-sectional area than the upper portion projectingcentrally within the housing proximal portion to the septum targetportion. The slit extends centrally through the septum extension.Providing a slot or a cutout of the lateral wall of the septum extensioncan provide the smaller cross-sectional area of the extension of theseptum. These slots or cutouts can be positioned in parallel alignmentwith the long transverse axis of the slit between the surroundinghousing and the lateral wall of the septum extension. The septum slot orcutout provides room for the expansion of the septum within the confinesof the proximal portion of the housing.

In one presently preferred embodiment, the septum further defines anenlarged enhanced sealing region adjacent the distal end of the septum.The slit of this sealing portion is tightly sealed. This may be achievedby a compression seal (of the type disclosed in U.S. Pat. No.5,466,219). Alternatively, another enhanced sealing configuration may beused. If the compression seal is used, the sealing portion preferablyhas a greater cross-sectional area lateral to the slit than either thelower portion or the upper portion. The larger area provides room forease of lateral septum displacement despite compression over a longerlength of the slit. Since the enhanced sealing portion may be positionedslightly distal to the maximum intussuseption length of the cylindricalluer lock connector, an improved seal can be provided in this portion bya longer compression seal along the slit since it is not necessary totightly constrain or minimize the vertical compressive interactionbetween the housing and septum in the manner discussed supra for theupper, the lower, and the extension portions of the septum.Alternatively, another short focused region of septum compression can beprovided along the housing or a septum sealing portion such as aduckbill portion (of the type disclosed in U.S. Pat. No. 5,474,544) maybe used.

It is an object and purpose of the present invention to provide aninexpensive, improved luer lock receiving septum having a configurationwhich provides rapid and tight resealing and yet allows penetration ofthe septum by the luer tip with a low penetration force.

It is yet a further object of the present invention to provide adeflection inducing member to provide opposing upward deflection of aseptum portion to lever closed a slit at the face of the septum.

It is also an object of the present invention to provide a septum facehaving a minimum effective diameter during luer penetration whileproviding a maximum diameter of the initial target for luer tipadvancement.

Another object the present invention is to provide an elongated septumhaving a central slit which includes an upper target face of enlargeddiameter wherein the septum includes a central lower septum extensionprojecting about the slit below the inlet and into a housing so that thenarrow extension can be more easily penetrated by entry into the narrowextension through the larger face and further so that there is providedsufficient room for both the laterally displaced extension of theseptum, the luer taper, and the housing to be received into aconventional luer lock connector.

It is a further object of the present invention to minimize or eliminatethe negative pressure deflection normally associated with the withdrawalof the large diameter luer cannula from an enclosed fluid filled lumenby providing isolation from the portion receiving the luer cannula by adistal sealing portion or by providing a septum extension around theslit which functions as a resting fluid displacement member and whichinhibits fluid from entering the insertion zone after withdrawal of theluer cannula.

It is further the purpose of the present invention to provide a face,which is comprised of a homogeneous elastomer, which can becomprehensively wiped. (This is similar to the conventional simplereseal used in medicine for decades) The present invention has no opencrevices or inaccessible spaces, which have contiguity with the luer,access face, or slit, or fluid path. There is no circumferentialpiston-to-cylinder space or crevice at the luer contact face of thevalve as is associated with the conventional luer access valves in wideuse. This space has the greatest potential for colonization. Itcomprises a circumferential crevice, which is in direct contact with theseptum face and it contacts the end of the luer tip and is in directcontiguity with the fluid path. Drops of fluid at the septum outer facewill contact both the circumferential crevice and the slit so thatcontamination contiguity from a microbiologic perspective is operativewith the first activation and at any time during subsequent use.Bacteria and fluid gaining entry into the circumferential crevice aredisplaced back and forth and are not accessible to wiping. Parenteralnutrition fluid gaining entry to the crevice provides a perfect culturemedium for rapid bacteria growth. This growth is inaccessible to wipingand is pistoned back and forth in direct contact with fluid droplets onthe outer face and the slit itself for potential entry into thepatient's blood stream.

It is further the purpose of the present invention to provide a longslit, which provides for a secure seal of the fluid path to reduce thepotential for bacterial egress.

It is further the purpose of the present invention to provide a highsurface sealing force as by compressive sealing which is applied andfocused directly at the surface by the lever action on the upper septumportion. This allows maximum tight sealing exactly at the surfaceinterface with the surrounding environment so tiny open crevices do notform at the surface exit point of the slit. This helps to prevent theegress of droplet contamination at the surface of the slit. This isadvantageous over transverse compression alone since a central slit willnot lever closed as tightly directly at the surface by transversecompression applied below the upper surface of the septum. Indeed if thesurface is induced into a convex configuration by transverse compressionthen there can be a tendency for slight gapping of the slit at thesurface.

It is further the purpose of the present invention to provide a septumwith relatively high mass so that the slit is more securely and morerobustly sealed in a range of usage situations.

It is further the purpose of the present invention to provide a simpleconfiguration having only a septum and outer housing, and wherein thereare no internal parts in contiguity with the fluid path.

It is further the purpose of the present invention to provide a wipingaction of the long septum on the luer tip, which wiping action can beexploited further by adding an antimicrobial agent to the elastomer asdiscussed below.

It is further the purpose of the present invention to provide a designwherein the entire contact between the luer tip and the valve is withthe elastomer.

It is further the purpose of the present invention to provide anantimicrobial barrier associated with the elastomer such anantimicrobial coating of the elastomer (as is known in the art) or as bymolding the septum from an antimicrobial elastomer (such antimicrobialelastomers are known in the art). This assures that a comprehensivebarrier is provided at all surfaces potentially contacting the luer tipduring insertion. Since the luer tip contacts only the elastomer duringand after insertion, there is no need to coat or otherwise applyantimicrobial to or within the housing structure although it may beapplied if desired.

It is further the purpose of the present invention to provide a distalseal in combination with a long slit which therefore allows a syringeattached to a luer tip extending through the septum to be decompressedupon partial withdrawal within the septum to avoid blood spurting duringblood sampling. (The background of the prevention of blood spurtingduring pressurized blood sampling can be reviewed in U.S. Pat. No.5,114,400, the disclosure of which is incorporated by reference as ifcompletely disclosed herein).

This invention also relates to medical containers including drug vials,and blood collection containers. There has been a longstanding need forluer access containers which can be manufactured at a very low cost,which provide a strong bi-directional seal during and after luerpenetration, which are comprised of conventional materials for whichdrug compatibility has been already established, and which do notrequire the addition of an internal spike for penetration of thestopper, which by its nature adds complexity and cost. Also suchinternal spikes remain in contact with the drug once the initialactivation has been performed so that issues of compatibility and theinternal spike arise if the drug vial is intended for multiple accessover several days as with many conventional drug vials.

The present invention comprises a container such as a drug vialincluding an open end sealed by a stopper. The stopper is preferablycomprised of a medical grade conventional elastomer such natural rubber,for example. Alternatively, and especially for use in evacuatedcontainers, a medical grade silicone or polyisoprene may be used, andmay have a hardness of 30-40 Shore A, for example. The stopper is heldin place by a stopper retainer which, for containers which serve as drugvials, is preferably comprised of metal crimp retainer. Alternatively, arigid plastic retainer such as polycarbonate may be used. In thepreferred embodiment, the retainer includes a portion for attachmentabout the open end of the container although the retainer may beintegral with the container open end. The stopper is mounted with theretainer such that the retainer and stopper present a upper elastomericportion having a target elastomeric face for engagement with the luertip and further to present a rigid surrounding portion about the facewhich is sized and configured to receive the threads of the luer lockconnector.

The stopper preferably includes a pre-slitted portion and may be slittedfrom both the upper surface and the lower surface, the slits preferablydo not extend completely through the stopper so that a complete seal isprovided for long term storage. The upper and lower slit may be formedby slitting, and may be slitted using the “anvil and blade method”, asis known in the art, to stretch and induce a very thin membrane.Alternatively the slits may be molded, as by the providing of aprojecting fine metal leaf into the stopper during molding, as is knownin the art. In one preferred embodiment, the first portion of the upperslit is molded and then the lower slit is extended by inserting an anvilinto the upper slit and then further slitting the lower portion using ablade to a predetermined point adjacent the upper face. In oneembodiment, the lower slit is pre-molded and the anvil is sized with theapproximate diameter of a luer cannula and can be inserted into the faceopposite the lower slit, achieving precise and focused stretching of themembrane before the blade is advanced to extend the lower slit tofurther thin and weaken the membrane. Alternatively, both the upper andlower slits can be pre-molded and either the upper slit or lower slitthen extended by the insertion of a luer diameter anvil into theopposing slit to stretch the membrane over the anvil and then applying ablade to further thin the membrane.

If the slits are molded, the stopper can be subsequently placed with theretainer and/or open container end in a slight state of compression soas to seal the molded slit. The upper and lower slits may be formed sothat an obliquely oriented membrane separates them so that the upperslit ends adjacent an oblique membrane to facilitate more easy ruptureby the advancing luer during operation. In one embodiment the membraneis positioned at a point wherein the luer tip forcefully engages onlyone portion of the membrane when the threads of the retainer have beenwell engaged with the luer lock threads so that the rupture of themembrane is facilitated by the mechanical advantage provided by thethreading process against a narrow focused region of maximally stretchedmembrane.

In another embodiment a membrane-cutting cap is provided wherein acutting member is provided within a cap member such as a luer cap. Thecap includes a projecting membrane-cutting member such as a spike ornarrow sharp edge blade to perforate the membrane prior to luer access.The cutting surface can be recessed within the cap so as to beinaccessible to human fingers.

BRIEF DESCRIPTION OF THE DRAWINGS

These, as well as other objects and advantages of this invention, willbe more completely understood and appreciated by careful study of thefollowing more detailed description of the presently preferred exemplaryembodiments of the invention taken in conjunction with the accompanyingdrawings, in which:

FIG. 1 is a longitudinal half-section of the luer penetration receiverof the present invention where the section is taken perpendicular to thecentral slit and wherein the receiver is rotated such that the wallslots are positioned to the right and left sides;

FIG. 1A is a longitudinal half-section of an alternate luer receiverhousing and septum in accordance with the invention;

FIG. 1B is a longitudinal half-section of the receiver housing of FIG. 1having a modified septum structure;

FIG. 1C is a longitudinal half-section of another alternate luerreceiver housing and septum in accordance with the invention;

FIG. 2 is a top view of the septum of the luer penetration receiver ofFIG. 1 without the housing;

FIG. 3 is a top view of the housing of the luer penetration receiver ofFIG. 1 without the septum;

FIG. 4 is a perspective view from above of a variant of the housing ofFIGS. 1 and 3;

FIG. 5 is a side elevational view of the housing of FIG. 4;

FIG. 6 is an end elevational view of the housing of FIG. 4;

FIG. 7 is a top view of the housing of FIG. 4;

FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 7;

FIG. 9 is a cross-sectional view taken along line 9-9 of FIG. 7;

FIG. 10 is a perspective view from above of a variant of the septum ofFIGS. 1 and 2;

FIG. 11 is a perspective view from below of the septum of FIG. 10;

FIG. 12 is a side elevational view of the septum of FIG. 10;

FIG. 13 is an end elevational view of the septum of FIG. 10;

FIG. 14 is a cross-sectional view of the septum of FIG. 12;

FIG. 15 is a cross-sectional view of the septum of FIGS. 10-14 mountedin the housing of FIGS. 4-9;

FIG. 16 is a perspective view of the cross-section depicted in FIG. 15;

FIG. 17 is a longitudinal half-section of another embodiment of thepresent invention wherein the section is taken perpendicular to thecentral slit and wherein the receiver is rotated such that the wallslots are positioned to the right and left sides;

FIG. 17A is an isometric side view of the embodiment of FIG. 17;

FIG. 18 is a longitudinal cross-section of a mock-up prop device createdto show the concept of U.S. Pat. No. 5,474,544 wherein the section istaken perpendicular to the central slit;

FIG. 19 is a longitudinal half-section of another embodiment of thepresent invention wherein the section is taken perpendicular to thecentral slit;

FIG. 20 is a view taken along line 20-20 of FIG. 19;

FIG. 21 is a longitudinal half-section of another embodiment of thepresent invention wherein the section is taken perpendicular to thecentral slit;

FIG. 22 is a view taken along line 22-22 of FIG. 21;

FIG. 23 is a longitudinal half-section of another embodiment of thepresent invention wherein the section is taken perpendicular to thecentral slit;

FIG. 24 is top plan view of the luer receiver of FIG. 23;

FIG. 25 is a sectional view of a septum provided in accordance with afurther alternate embodiment of the invention;

FIG. 26 is an exploded perspective view of a presently preferredembodiment of the invention incorporated in a Y-site;

FIG. 27 is top plan view of the luer receiver Y-site housing base of theembodiment of FIG. 26;

FIG. 28 is side elevational view of the luer receiver Y-site housingbase of the embodiment of FIG. 26;

FIG. 29 is a cross-sectional view taken along line 29-29 of FIG. 27;

FIG. 30 is a cross-sectional view taken along line 30-30 of FIG. 27;

FIG. 31 is top plan view of the luer receiver housing body of theembodiment of FIG. 26;

FIG. 32 is a side elevational view of the luer receiver housing body ofthe embodiment of FIG. 26;

FIG. 33 is an end elevational view of the luer receiver housing body ofFIGS. 31 and 32;

FIG. 34 is a cross-sectional view taken along line 34-34 of FIG. 31;

FIG. 35 is a cross-sectional view taken along line 35-35 of FIG. 31;

FIG. 36 is top plan view of the luer receiver septum of the embodimentof FIG. 26;

FIG. 37 is a side elevational view of the luer receiver septum of theembodiment of FIG. 26;

FIG. 38 is an end elevational view of the luer receiver septum of FIGS.36 and 37;

FIG. 39 is a bottom plan view of the luer receiver septum of FIGS. 36,37, and 38;

FIG. 40 is a cross-sectional view taken along line 4040 of FIG. 36;

FIG. 41 is a cross-sectional view taken along line B-B of FIG. 36,showing an alternate slit configuration in accordance with theinvention;

FIG. 42 is a cross-sectional view taken along line B-B of FIG. 36,showing a second alternate slit configuration in accordance with theinvention;

FIG. 43 is an exploded perspective view of another embodiment of theinvention incorporated in a Y-site;

FIG. 44 is top plan view of the luer receiver upper housing body of theembodiment of FIG. 43;

FIG. 45 is a side elevational view of the luer receiver housing body ofFIG. 44;

FIG. 46 is another side elevational view of the luer receiver housingbody of FIGS. 44 and 45;

FIG. 47 is a cross-sectional view taken along line 47-47 of FIG. 44;

FIG. 48 is a cross-sectional view taken along line 48-48 of FIG. 44;

FIG. 49 is a side elevational view of the luer receiver septum of theembodiment of FIG. 43;

FIG. 50 is another side elevational view of the luer receiver septum ofFIGS. 44 and 49;

FIG. 51 is a cross-sectional view taken along line 51-51 of FIG. 50;

FIG. 52 is a cross-sectional view taken along line 52-52 of FIG. 49;

FIG. 53 is a cross-sectional view of a further alternate luer receiverseptum embodying the present invention;

FIG. 54 is a schematic cross-sectional view of the luer receiver septumof FIG. 53, before luer tip insertion;

FIG. 55 is a schematic cross-sectional view of the luer receiver septumof FIG. 53, after luer tip insertion;

FIG. 56 is an elevational view showing a housing body and septum inaccordance with the invention mounted to a housing base defined by andrug vial, in accordance with another exemplary implementation of theinvention;

FIG. 57 is an elevational view showing a housing body and septum inaccordance with the invention mounted to a housing base defined by anintravenous fluid bag, in accordance with a further exemplaryimplementation of the invention;

FIG. 58 is an elevational view showing a housing body and septum inaccordance with the invention mounted to a housing base comprising bloodtubing access port, in accordance with yet a further exemplaryimplementation of the invention;

FIG. 59 is an elevational view showing a housing body and septum inaccordance with the invention mounted to a housing base defined byvacuum blood or specimen collector, in accordance with yet anotherexemplary implementation of the invention.;

FIG. 60 shows a male luer tip and a septum in accordance with a furtheralternate embodiment of the invention;

FIG. 61 is a plan view of the septum of FIG. 60;

FIG. 62 is a view taken along line 62-62 in FIG. 60;

FIG. 63 is a schematic part cross-section view of a luer receiver forreceiving the septum of FIGS. 60-62;

FIG. 64 shows a modification of the septum shown in FIG. 62;

FIG. 65 shows a cross-section of a blood collector and septum inaccordance with yet a further feature of the invention;

FIG. 66 shows a cross-section of a further embodiment of the septum ofFIG. 65;

FIG. 67 is a schematic cross-section of a minimal deadspace stopcockwith luer receiver in accordance with the invention;

FIG. 68 is a schematic cross-section of another minimal deadspacestopcock having two luer receivers in accordance with the invention;

FIG. 69 is an elevational view showing two luer receivers mounted to ahousing base defined by an a catheter, in accordance with a furtherexemplary implementation of the invention;

FIG. 70 is an elevational view showing a housing body and septum inaccordance with the invention mounted to an intravenous line, inaccordance with a further exemplary implementation of the invention;

FIG. 71 is a broken, half-section view of the luer access containeraccording to the present invention;

FIG. 72 is a half-section view drawn through line 72-72 of FIG. 75 ofthe membrane-perforating cap;

FIG. 73 is a cut, half-section view of an alternative embodiment of aluer access container according to the present invention;

FIG. 74 is a side view of the membrane-perforating cap according to thepresent invention;

FIG. 75 is an isometric view of the membrane-perforating cap accordingto the present invention; and

FIG. 76 is a cut section view of the septum showing an obliqueorientation of the membrane.

DESCRIPTION OF THE PRESENTLY PREFERRED EXEMPLARY EMBODIMENTS

As shown in FIGS. 1, 2, and 3, the luer lock receiver 10 comprises ahousing 12 including an proximal portion 14, a central portion 16, and adistal portion 18 having a distal lumen 20. The proximal portion 14 hasan inlet 22, and interior walls 24 defining an intermediate space orbore 26 and outer threads 28 and is sized to be threadably received intoa conventional luer lock 30 with male luer tip and a surrounding femalethreaded end. Bore 26 is sized to receive a conventional luer cannula32. A septum 34 has a proximal portion that, in this embodiment,includes a widened upper portion 36 and a narrower lower portion 38. Theseptum 34 further has an extension 40 that is received intermediate theinterior walls of the housing 12. A central slit 42, sized to snugly-receive the luer cannula 32, is provided to extend from adjacent theupper face of the upper portion 36, through the proximal portion ofseptum 34 and at least partly through the extension 40. In theembodiment of FIG. 1 the slit extends through the extension 40 into adistal septum portion 72 (discussed below). However, as is alsodiscussed herein below, the slit is preferably incomplete as shown at 71to provide a hermetic seal prior to first penetration. The septum can beformed of polyisoprene, although other similar medical grade materialmay be used including silicone rubber. The preferred durometer fallswithin the range of conventional durometers of medical septae for IV andarterial line tubing reseals in wide use and employed for penetration bycannulae including blunt cannulae. One example of acceptable elastomericseptum material is the material which is used to form the blood accesssepta of the SAFESET™ arterial line marketed by Abbott Laboratories(List No. 42644-06). The septum elastomer durometer can, for example, bein the range of 30.

The housing inlet 22 includes an inlet wall platform or ring 44 definingplatform elevations 46 positioned parallel to the long transverse axisof the slit 42. The upper surface of the platform 44 slopes upwardlyfrom opposing trough portions 48 (FIG. 3). The trough portions 48 arepositioned adjacent and aligned perpendicular to the ends of the slit 42to create a low point of the housing inlet 22 adjacent the ends of theslit 42. The opposing platform elevations 46 can be configured andoriented such that they readily engage the internal threads of theconnector 30 adjacent the highest point of the platform 44. The platformelevations include opposing internal projections 50 oriented to projecttoward the bore 26. The projections 50 are preferably narrow and can betapered or pointed so the septum lower portion 38 can be easilycompressed laterally against the narrow projections 50 and can beexpanded around the projections 50 when the luer tip is advanced throughthe slit 42 (as will be described). The septum 34 has opposing grooves52 to receive the projections 50. The lateral transverse dimension ofthe septum 34 intermediate the grooves 52 (and perpendicular to the slit42) is slightly greater than the corresponding intermediate internallateral dimension of opposing projections 50 so that the septum 34 isslightly compressed transversely by the opposing projections 50. When atrest, the septum lower portion 38 is preferentially not substantiallycompressed along an axis extending between trough portions 48 since thiswould potentially bias the slit toward the open position.

As shown in FIG. 1, a parallel slit 54 extending from grooves 52 of thelower septum portion intermediate the opposing projections 50 can beprovided to further reduce the force required for expansion of the lowerseptum 38 and allow for enhancement of the upward wedged configurationto be described. A portion 47 of the lower septum 38 can expand into theslot 68 provided under the circumferential platform 44. Opposing angledupper surfaces 56 of the projections 50 are provided along the platformelevations 46. The angled upper surface 56 fit into lateral slits orgrooves 52 and upwardly wedge the opposing lateral elevated septumportions 58 of septum upper portion 36 to define a curved face 60 withthe central slit 42 aligned between elevated septum portions 58. Theslit is positioned centrally and aligned with the longitudinal axis ofthe curved face 60. The central slit 42 is tightly closed by the leveredforce of the wedged elevated septum portions 58 which is focused uponthe central slit 42.

The septum extension 40 has a transverse width and thus cross-sectionalarea smaller than the transverse width (and cross-sectional area) ofupper portion 36. The extension 40 includes lateral walls 62 alignedwith and adjacent the central slit 42. The extension 40 is positionedwithin bore 26 and includes a thinner portion 64 with a transversewidth, and therefore cross-sectional area, smaller than the transversewidth (and cross-sectional area) of the bore 26 to define opposingseptum slots or cutouts 66 which are aligned with opposing wall cutouts68 in the proximal housing 14. Where a threaded shroud 30 is to bereceived over and about housing 12, the volume of the cavity(ies) orvoids defined by the combined volume of the cutouts 66, if any, and thecutouts or slots 68, if provided, is such that at least the volume ofthe portion of the septum 34 laterally displaced by insertion of themale luer tip can be accommodated, so that the septum and housing andthe penetrating luer taper can be contained within the confines of acylindrical luer lock connector.

The central housing portion 16 defines opposing lateral slots 70 forreceiving an enlarged sealing septum portion 72. The sealing septumportion 72 is compressed at an increased distance from the central slit42 by opposing walls 74 transverse to the long transverse axis of thecentral slit 42 to enhance the sealing of the slit 42. The sealingseptum portion 72 fits relatively flush against the wall 76 adjacent theslit 42 to minimize downward deflection associated with penetration ofthe sealing septum portion 72 into the lumen 20 to minimize thepotential of negative pressure deflection within lumen 20 uponwithdrawal of the luer cannula 32. Lateral deflection can be enhanced byreducing or eliminating the compression of the most distal segment ofthe sealing septum portion 72 immediately adjacent the lumen 20.Additional opposing cutouts 78 can be provided in the lateral portion ofthe sealing septum 72 to allow a portion of the septum extension 40 massto more easily expand downward into the slots 70. The sealing septumportion 72 serves to isolate the proximal housing bore 26 which actuallyreceives the greatest volume of the luer cannula 32 from the fluidfilled distal lumen 20 to prevent the development of negative pressurewithin the lumen 20 upon withdrawal of the luer tip 32. The septumextension 40 isolates the slit 42 from the proximal housing bore 26 andserves to displace the fluid volume from this bore thereby alsoinhibiting flow into the bore 26 and the attendant negative pressuredeflection even when an isolating distal sealing septum 72 is notprovided.

In operation, the luer cannula 32 penetrates by entering at the curvedface 60 and tips deflecting or lateral portions 58 of the upper septumportion 36 upward to be captured within the cylindrical luer lockconnector 30. Further downward advancement of the luer cannula 32 alsoexpands the lateral walls of the upper septum portion 36 to compressagainst the opposing narrow projections 50. This compression is focusedby the opposing narrow projections 50 and can be overcome by theinsertion of the luer tip because of the matched shape of the inletplatform 44 and septum 34 allows for expansion around (above and below)the inlet platform 44. Despite the focused compression force at thisregion, penetration is easily achieved through this region by thereceptive configuration of the levered septum upper portion 36 and byexpansion of the septum 34 around the narrowed projection 50 above andbelow the platform 44. As the luer cannula 32 advances further, thelateral walls 62 of the septum extension 40 are then deflected into thespaces provided by the septum cutouts and the housing slots. A portionof the septum extension 40 is also deflected into slot 70. As the luercannula 32 is advanced distally through slit 42, it displaces thesealing septum portion 72 laterally to open fluid communication betweenthe luer cannula 32 and the distal lumen 20.

The length of the proximal housing portion 14 is sized to allow the luerlock connector 30 to be fully threaded onto the proximal portion 14. Inone embodiment the length of the septum is provided so that the luertaper tip upon maximum penetration reaches to a position within the slit42 just proximal to the end of the sealing septum. The large relativediameter of the luer cannula 32 will hold a portion of the central slit42 open beyond the tip of the cannula 32 so that precise positioning isless critical. This can be employed to further reduce the potential forthe induction of negative fluid pressure deflection upon withdrawal ofthe luer tip.

The presently preferred width of the curved or atmospheric face 60 canbe in the range of about 8 mm by 7 mm with the long axis extending alongthe long transverse axis of the central slit 42. The central slit 42 canhave a length along its long transverse axis of about 3-5 mm. Thelateral housing slots 68 can be about 7 mm wide by 4 mm in length. Theplatform upper surfaces 56 can be angled upward in the range of about30-45 degrees. The lateral grooves 52 and extending lateral slit 54 inthe lower septum portion can be about 2 mm-2.5 mm in depth (whenmeasured at the point along face 60 of maximum depth of the grooves 52and lateral slits 54). The septum 34 as mounted with the extension canbe about 8-11 mm in length. The upper portion of the septum can be about1-1.5 mm in thickness but may be extended to 2 mm if desired. Thesealing portion can be in the range of 2-15 mm in length. Each of thelateral walls of the septum extension can be about 2.5-3 mm in width ifopposing cutouts 68 through the proximal housing walls are provided. Itshould be clear that these dimensions represent only presently preferreddimension ranges and other ranges can be employed or may be learned bypractice of the invention. Moreover, the extension cutouts could be moredeeply concave in the transverse plane resulting in very thin lateralwalls adjacent the central slit.

Referring again to FIG. 1, a simplified embodiment can be providedhaving the septum configuration of FIG. 1 with an upper portion 36 and alower portion 38 but without an extension 40. The septum is sealed intothe housing 14 along the ring 44. This configuration is particularlysuited for use with a luer docking station or other simple luer lockreceiving systems which do not require protection against leakage undervery high internal pressure (although a means for enhanced sealing asadjacent ring 44 can be included if enhanced sealing is desired).

FIGS. 4-16 illustrate a modified version of the embodiment of FIGS. 1-3,in which corresponding structures are illustrated using the samereference numerals denoted with the prime symbol (′). In this version,the extension cutouts 66′ are more deeply concave in the transverseplane resulting in thin lateral walls adjacent the central slit 42′.Furthermore, in this adaptation, rather than providingthread(s)/groove(s) 28, luer ears or projections 27 are defined on theexterior surface of the housing proximal portion 14′ for engaging theluer threads of connector 30. Otherwise, the structure illustrated inFIGS. 4-16 generally corresponds to that shown in FIGS. 1-3. Inparticular, the housing 12′ includes proximal portion 14′, a centralportion 16′ having cutouts 68′, and a distal portion 18′. In thisexample, cutouts 68′ are defined entirely through the housing wall. Theinlet end of the housing includes an inlet wall platform or ring 44′defining opposing trough portions 48′ and platform elevations 46′. Theplatform elevations 46′ include opposing internal projections 50′.

The septum 34′ has a widened upper portion 36′, an extension 40′ and anenlarged distal sealing septum portion 72′ including opposing cutouts78′ which allow a portion of the septum mass to more easily expand intohousing slots 70′. FIGS. 10, 11,13 and 14 most clearly depict thedeflection reservoirs or cutouts 78′ provided in the distal septumportion 72′. As in the embodiment of FIG. 1, a slit 42′ is definedlongitudinally through the septum 34′. In this example, however, slit42′ is defined all the way through the septum 34′, as can be seen fromFIG. 11.

The septum 34′ has opposing grooves 52′ to receive projections 50′.Portions 47′ of the septum 34′ extend under projections 50′ whereasopposing angled upper surfaces 56′ of projections 50′ fit into grooves52′ adjacent slits 54′. This wedges elevated septum portions 58′ ofupper septum portion 36′ to define a curved face 60′ with the centralslit 42′ aligned between septum portions 58′. As with the structureshown in FIG. 1, the central slit 42′ is tightly closed by the leveredforce of the wedge septum portions 58′, which is focused upon centralslit 42′.

As will be recognized from a consideration of the luer receiverdisclosed with reference to FIGS. 1-16, above, the luer receiver of theinvention is intended and may be adapted for universal use. To that end,the luer receiver can be constructed as a two or more part housing, forexample, a housing body and housing base that capture the septumtherebetween. Alternatively, the septum may be inserted into an integralhousing structure.

Referring to FIG. 17, a another embodiment of the present invention isshown. The corresponding components of the embodiment in FIG. 1 aredesignated with the same or similar reference number advanced by 100.The upper housing and septum are identical to the correspondingcomponents of FIG. 1. However, this embodiment shows an extension with adistal focused sealing region 180 within the housing midportion 114. Thefocused sealing region 180 includes narrow lower projection 182 whichcompress the extension 140 between lower projections 182 which functionin a manner similar to that described for the projections 50 of FIG. 1.

The housing slots can be covered and a means for rebounding the thinlateral walls of the cutout extension could be provided intermediate theextension walls and the slot cover. A highly compressible filter, suchas the type disclosed in U.S. Pat. No. 5,474,544, could be providedlateral the extension (See, e.g. FIGS. 21, 22, and/or 25). This could beused as another means to rebound the extension walls and also means toprevent fluid flow within the portion of the housing receiving the luertip and to provide an expansion member, which fills the volume, vacatedby the luer tip upon withdrawal.

FIGS. 19-25 show various alternative septum configurations for mountingwith housing structure having a similar proximal portion to that of thehousing 10 of FIG. 1. These figures illustrate the incorporation ofdifferent septum extensions and sealing members along with the basicupper septum configuration of FIG. 1.

FIG. 19 and FIG. 20 show an embodiment having an extension 240 withdeeper concave septum cutouts 266 and very thin portions 264 of lateralseptum walls 262 which are supported by narrow transverse discs 284which extend between the concave lateral septum walls 262 and housing214. The housing 214 is of substantially uniform thickness throughoutits circumference (except for external thread receiving recesses 228).The cutouts 266 are deeper than the septum cutouts 66 of FIG. 1 toaccommodate the additional volume of the proximal housing 214 within thetransverse axis of deflection of the septum lateral walls 262. The discs284 function to enhance the decreased rebound force associated with theloss of elastomeric mass associated with thinning the septum walls 262in this region so that withdrawal of the luer cannula, discs 284 reboundthe lateral walls 262 to return the slit 242 to a closed position. Thecombination of thinner lateral septum walls 262 and discs 284, helps toreduce the need for the provision of corresponding cutouts in theproximal housing 214 or limits the need for such cutouts to penetratetransversely all of the way through the lateral housing wall. Thisconfiguration is made possible by the projecting members 250 andplatform 244 which comprise holding members holding the thin walledextension 240 up by engaging the lateral portion of the proximal portionof the septum (upper portion 236 including elevated portions 258 and thelower portion intermediate projections 250) to hold the extensionagainst forcible longitudinal pressure during advancement of the tipagainst the septum face. These holding members thereby preventlongitudinal collapse of the thin portions 264 of lateral septum walls262 of the extension 240 during luer insertion.

FIG. 21 and FIG. 22 show alternative embodiments with a modifiedextension 340 and cutouts 366. The embodiment is otherwise unchangedfrom the embodiment of FIG. 19. The modified cutouts 366 can be filledwith a highly compressible material 386 having a high resting volume anda low compressed volume such as medical foam rubber to eliminate anyresidual resting dead space and to facilitate deflection back to theresting position upon luer cannula withdrawal. The extension 340 now isconfigured as a thin rectangular rod or beam surrounded by the highlycompressible member 386. If the cutouts 366 are so filled the need forthe transverse discs as shown in FIG. 19 is obviated.

FIGS. 23 and 24 shows the basic configuration of FIG. 19 wherein thecutouts 466 in the septum extension are less deep and correspondingtransverse housing cutouts 468 producing recesses directly within theproximal housing 414 are provided. Opposing outer struts 488 areprovided to provide outer support for the luer lock connector when ithas been threaded onto housing 414.

FIG. 25 shows another septum embodiment 534 having a septum extension540 mounted with a lateral highly compressible member 586. The septum534 is configured for mounting within a housing such as that shown asthe proximal housing 414 of FIG. 23 or 214, 314 of FIGS. 19-22. Note theprovision of the compressible member intermediate the proximal housingand septum extension to fill the lateral receptive space between thesestructures formed by their respective cutouts. In aggregate, the tinyair spaces of the foam rubber are functionally analogous to open cutoutspaces in that they receive the expanded mass of the lateral walls 562.While the enlarged sealing member of FIG. 1 serves to isolate the distalfluid chamber from the septum cutouts, if the sealing member is notprovided or is not configured to provide this function, the compressiblemember serves to maintain resting displacement of fluid from the cutoutarea lateral the extension thereby minimizing negative fluid deflectionupon withdrawal of the luer cannula. A distal duckbill valve sealingmember 590 projects from the extension 540. The duckbill valve alsominimizes negative fluid deflection as it opens and closes with minimalmaterial displacement and precludes fluid counter flow upon luerwithdrawal.

A general description several presently preferred embodiments of theinvention is as follows:

A luer receiver for receiving a luer lock connector, the receiverincludes a housing defining a longitudinal axis and an elastomericseptum mounted with the housing, the septum defines a longitudinal axisand includes an upper portion defining an upper face, an elastomericseptum extension projects distally from the upper portion within thehousing. The septum includes a sealed perforation extending through theupper portion and at least partially through the extension. The sealedperforation is preferably a sealed slit and positioned centrally alongthe longitudinal axis of the septum and centrally along the longitudinalaxis of the extension. The slit defines opposing internal walls whichcontact each other to seal the slit, the internal walls preferablyextend from the upper portion into the extension and thereby comprisesan uninterrupted sealed slit entirely through the central portion of theextension without resting deadspace so that fluid is not retained in theslit when the luer cannula is not within the slit. The extensionpreferably has a smaller transverse width than the upper septum portionand can include diametrically opposing cutouts defining outwardly facingconcavities which may be oriented in the longitudinal axis or transverseaxis or along both axes. The thin extension walls provide for thedisplacement of the lateral walls of the extension to occur within theboundaries of the threaded luer lock connector. However an unexpectedresult of this thinning is a particularly favorable penetration forcecurve for the insertion of the luer tip. The luer tip “pops through” thenarrow upper portion including any narrow zone of focused compression toenter the zone of the extension which provides for easy penetration.However, because the extension is preferably of narrow width and iscomprised of a soft and elastic elastomer to allow easy elasticdisplacement, the extension is held to prevent longitudinal collapsewhen a forcible longitudinal force is applied against it to enter thesealed slit. For this reason the receiver further includes a holdingmember, such as the upper portion of the housing which can be configuredto form a plateau or buttress or which can project into a recess in theupper portion or can otherwise hold the upper portion, the holdingmember holds the extension against excessive downward deflection orcollapses into the housing despite its preferred configuration withlimited side wall thickness and therefore limited longitudinal support.The holding member holds the upper portion adjacent the proximal end ofthe housing so that the upper portion is held in a position adjacent theend when the luer tip is forcibly pressed against the upper portion. Theextension, which is preferably integral with the upper portion, andthereby held by the upper portion in a receptive position to receive thelarge luer tip into the slit of the extension because the extension ispositioned in a relatively fixed position along the longitudinal axis ofthe housing by the upper portion. Indeed the extension can be seen to besuspended from the upper septum portion and from the holding member.

In a preferred embodiment the extension comprises an elastomeric rod orbeam including a central slit which is closed along its entire lengthand held in a suspended position from a septum mounted with the proximalend of the housing, wherein the slit is connected with the perforationthrough the septum. This configuration allows the large diameter luercannula to penetrate into the narrow and thin walled rod from the upperportion of the septum without longitudinally collapsing the rod. The rodthereby provides an enclosed and sealed perforation or slit, which isclosed along its entire length projecting distally within the housingtoward the outlet.

The septum preferably includes at least one sealing region positionedalong the septum where the perforation or slit is tightly sealed. In apreferred embodiment a plurality of sealing regions are provided. Theseregions can be provided by configuring at least one of the septum andthe housing such that the opposing inner walls of the slit press moretightly against each other within these regions than along the slitimmediately adjacent the outer face. This allows easy penetration at theouter face but ensures tight sealing. The regions of increased pressingcan be provided by using thicker elastomeric walls adjacent the regionor by configuring the housing and the septum such that the housingsqueezes against the septum to thereby deflect the opposing walls intomore tight opposition within the regions. At least one of the sealingregions is preferably of a length less than one half the total length ofthe slit and is defined by a focused region of compressive force appliedto the septum by projecting compressing members of the housing.

In the preferred embodiment the two opposing slit walls of the septumwhich define and bound the closed slit are preferably deflected by theadvancing luer tip laterally to a greater extent than they are deflecteddownwardly into or within the housing. Furthermore, rather than solelyswinging open about a laterally fixed axis so that the opposing wallsface downward in the open position, the opposing slit walls preferablyspread transversely apart to a greater extent than they swing downwardupon receipt of the luer tip such that the slit walls continue to facesubstantially toward each other after the luer tip has been insertedinto the slit. This feature is important since downward displacementinto the housing increases the septum mass within the housing therebyfurther compromising the limitations of space previously discussed. Ifthe slit walls swing downwardly the thickness of the downward projectingwalls is added to the volume of septum which must be laterally displacedby the penetrating luer tip. As taught supra, the upper portion of theseptum is preferably of greater diameter than the portion immediatelybelow the upper portion. The upper portion is preferably circular and ispreferably buttressed by a wall or plateau, which is preferably acomplete ring but may extend only partially about the circumference ofthe upper portion. The upper portion is held in place along or adjacentthe lateral wall of the upper portion to prevent downward displacementof the lateral portion of the upper portion. The lateral portion of theupper portion is preferably more fixedly held against downwarddisplacement than the more central portion adjacent the slit so thatcentral downward deflection toward the housing bore is induced bypressing a luer tip against the central portion. However the septum andhousing are configured such that the portions of the septum lateral tothe long axis of the slit deflect laterally to a greater extent thanthey deflect downwardly into the housing. The housing is configured toprovide for this lateral deflection of the septum above, within and/orabout the housing.

In a presently preferred embodiment an axis of maximum transversedisplacement of the extension is provided along a transverse axisdefined perpendicular to the midpoint of the long transverse axis of theslit. The focused nature of the maximum displacement is achieved byproviding a slit, which is nearly equal to the size of the luer tip, sothat the midpoint of circular cross-section of the luer tip predictablyfalls at the midpoint of the slit. The regions of reduced housing wallvolume and/or reduced septum wall volume are then positioned to bealigned within the axis of maximum displacement. As previously shown,the transverse section of the septum extension cutout can be concave tomatch the corresponding circular cross-section of the luer tip so thatthe center portion of the lateral wall of the extension is thinner thanthe more lateral portion. The corresponding degree or depth of thecutout in the internal wall of the housing facing the septum cutout canbe matched so that the deflection of the extension can be accommodatedby the space intermediate the lateral wall of the septum cutout and theinner wall of the housing cutout. Such housing cutouts can be seen toinclude many configurations and combinations such that the deflection ofthe lateral walls of the septum extension is accommodated withinconfines of the luer lock connector.

As discussed previously, in one embodiment the extension of the septumincludes highly compressible members mounted adjacent the extension andpreferably within the cutouts. These compressible members can beportions of the extension configured to be easily compressed such asvertical or horizontal thin walled discs projecting to the interior wallof the housing or can be provided by a filling material mounted withinthe cutouts which is inherently highly compressible. These compressiblemembers are particularly for use when the cutouts in the housing wall donot extend all the way through the wall so that the extension isenclosed as by a complete circumferential housing wall provided aboutthe extension. When thin discs are used the spaces or cutouts of thelateral wall of the septum extension are provided between the discs toaccommodate lateral deflection when the luer tip is inserted into theslit. The use of laterally oriented narrow discs presents a minimum ofcross-sectional area of the septum for compression against the interiorwall of the housing. Preferably the discs are aligned with the longtransverse axis of the slit. These discs may be slightly compressedagainst the housing at rest to more tightly seal the slit but aremarkedly compressed against the interior wall when the luer tip isreceived into the slit.

Medical liquid can be transferred between a medical liquid storagecontainer and a chamber using a luer lock connector, the connectorhaving a central male luer cannula defining an outer cannula wall, theconnector being mounted in fluid connection with the container, thechamber having a luer receiver mounted with the chamber, the receiverincluding a housing having an inlet, the housing containing a sealingseptum mounted adjacent the inlet, the septum having an upper portionincluding an outer face and a slit defining a long transverse axisextending through the face, the slit defining two lateral opposing wallsdefining two opposing inner faces bounding the slit, the opposing facescontacting each other to seal the slit, the septum including a distalseptum portion projecting within the housing, the slit extending atleast partially through the distal portion, the receiver including amember for engaging the upper portion of the septum, wherein the methodincludes steps of:

-   1. pressing the luer tip against the outer face, the member holding    the upper portion of the septum in a position adjacent the inlet    such that the upper portion is held while the luer tip penetrates    into the slit and into the outer face of the septum,-   2. deflecting the slit walls laterally such that the opposing inner    faces directly press against the outer cannula wall after the luer    tip has been advanced into the slit,-   3. threading the luer lock connector about the housing such that the    septum, the luer tip, and at least a portion of the housing are    retained within the luer lock connector, and-   4. flowing liquid through the luer tip and into the chamber.

Another method of transferring medical liquid between a medical liquidstorage container and a chamber can be performed using a threaded luerlock connector, the connector having a central male luer cannula, theconnector being mounted in fluid connection with the container, thechamber having a luer receiver mounted with the chamber, the receiverincluding a housing having an inlet, the housing containing a sealingseptum mounted adjacent the inlet, the septum having an upper portionincluding an outer face and a perforation, the septum including a distalseptum extension projecting within the housing the perforation beingcircumferentially enclosed by the extension and extending at leastpartially through the portion, the receiver including a member forengaging the upper portion of the septum, the method comprising stepsof:

-   1. pressing the luer tip against the outer face, the member holding    the upper portion of the septum in a position adjacent the inlet    such that the upper portion is held while the luer tip penetrates    into the slit and into the outer face of the septum and into the    extension,-   2. deflecting the extension laterally with the luer cannula such    that the extension is elastically expanded within the housing in    direct contact with the male luer cannula the cannula penetrating at    least partially through the extension into fluid connection with the    chamber,-   3. threading the luer lock connector about the housing such that the    upper portion of the septum, the luer tip, at least a portion of the    extension, and at least a portion of the housing is retained within    the threaded luer lock connector,-   4. flowing liquid through the luer tip and into the chamber.

Another method of transferring medical liquid between a medical liquidstorage container and a chamber can be performed using a threaded luerlock connector, the connector having a central male luer cannula, theconnector being mounted in fluid connection with the container, thechamber having a luer receiver mounted with the chamber, the receiverincluding a housing having an inlet. The method can includes steps of:

-   1. Attaching an elastomeric septum having a perforation defining a    longitudinal axis to the receiver adjacent the inlet of the housing.-   2. Suspending an elastomeric rod from the septum into the housing    the rod having a sealed lumen defined by opposing internal walls.-   3. Inserting the male luer into the perforation of septum, the    perforation directing the male luer into the lumen, the male luer    deflecting said internal walls to open the lumen as the male luer    passes into the rod.-   4. Flowing liquid through the male luer and though the lumen into    the chamber.

As noted above the housing and the suspended rod within the housing canbe sized and configured such that the entire rod remains within theconfines of the threaded luer lock connector when the male luer has beenreceived into the lumen and the connector has been threaded onto thereceiver. The rod and housing can be further configured such that therod is entirely contained within the housing when the connector has beenthreaded onto the receiver.

Many additional modifications are included within the scope of thisteaching. For example, an embodiment (not shown) for penetration by amale luer can include a combined integral housing and septum comprisedof a single elastomer having regions of different durometers wherein thecentral penetrable portion has a low durometer such as 20-30 and theoutside thread-able portion has a high durometer such as 70-80. In sucha structure wherein the housing and septum have no definable boundaries,the cutouts nevertheless preferably comprise elongated concave cutoutsor recesses within a distally projecting elastomer wherein the cutoutsextend longitudinally lateral to a central and longitudinally projectingslit within the elastomer to allow deflection of the elastomer withinthe confines of the threaded luer lock connector.

Referring now to FIG. 26, there is shown therein an exploded perspectiveview of a presently preferred embodiment of the luer receiver of theinvention, incorporated in a Y-site. More particularly, referring to theviews of FIGS. 26-42, the luer receiver of this embodiment isconstructed from a two-part housing including an upper housing body 612a and a housing base 612 b. The upper housing body 612 a includesproximal portion 614 and central portion 616. The housing base 612 bcomprises the distal portion 618 which in the illustrated embodiment isconfigured as a Y-site. The upper housing body 612 a and housing base612 b have a complementary shape for being operatively engaged,capturing the septum 634 therebetween. Thus, in the illustratedconfiguration, the end wall 674 and side walls of the upper housing body612 a define a bottom peripheral surface 677 sized for engaging acomplementary ledge 679 defined on housing base 612 b. Furthermore,spaced projections 671 project inwardly of the central portion 616 ofupper housing 612 a for selectively being received vertically below aperipheral projection or rim 673 on housing base 612 b, to snap lock thehousing parts together.

Similar to the structure shown in FIGS. 4-16, projecting luer ears ortabs 627 are defined on housing proximal portion 614. Moreover, as inthe prior embodiments, housing recesses or cutouts 668 are also definedin the proximal portion 614 of the housing for allowing lateraldeflection the walls of extension portion 640 at cutouts or recesses666.

As in the embodiments described above, septum 634 has an enlarged upperportion 636 for being seated on elevated portions 646 and troughportions 648 of the proximal portion 614 of the housing. Slots 654 aredefined between upper septum portion 636 and lower septum portion 638for allowing the upper septum 636 to deflect upwardly for being seatedon upper surfaces 656 of projections 650 along the platform elevations646.

The upper surface of septum 634 in this embodiment is defined as adish-shaped upper surface 660. Thus, as shown for example in FIG. 40,the outside rim of the septum upper disk 638 is thicker than the centerthereof. The dish shape serves two purposes. The first is to keep theluer tip centered on the top surface of the septum when accessing theY-site. The second purpose of the dish shape surface is to create moreinterference with upper body 612 a to reduce the chance that the septumupper portion 636 will pass through the top of the body during access.

A further feature of the embodiment illustrated in FIGS. 26-42 is theprovision of support ribs 645 on the sides of septum 634. Moreparticularly, septum 634 has lower septum portion 638 as a compressionring just below side cuts 654. This compression ring 638 is compressedin two directions by projections 650 of the upper body 612 a. When theproduct is accessed, the compression ring is moved down and out ofcontact with a body thus relieving the compression. Ribs 645 give thecompression ring the support necessary to re-engaged the compressionring after removal of the accessing luer.

To position and mechanically lock the luer receiver components together,the lower portion 672 of septum 634 has on a bottom surface thereof twoprotrusions 669 that project downwardly therefrom, extend generally inan arc, and are located near the outer periphery thereof. The bottomY-site 618 has corresponding holes or receptacles 675 for receivingprotrusions 669, to correctly position and laterally lock septum 634relative to be housing parts 612 a and 612 b. Thus, during assembly,septum 634 is seated on upper wall 676 of Y-site 618 with protrusions669 disposed in holes or receptacles 675. The housing body 612 a is thenfirmly attached to the bottom Y-site 618 by snapping protrusions 671past rim 673, with the septum 634 compressed between housing parts 612 aand 612 b. The upper surface 676 of bottom Y-site 618 provides supportto the septum 634 close to the duckbill 643 defined at the distal end ofslit 642. The protrusion of the septum 634 into the holes or recesses675 of the Y-site 618 provides a mechanical entrapment to maintain theposition of septum 634 within the housing provided by the combination ofthe Y-site and the upper body 612 a. This reduces the chance the septumcould be deformed and become unseated, thus compromising the fluid sealbetween the septum and Y-site structure. It also reduces the chance theseptum could be removed from the housing.

Referring now to FIGS. 41 and 42 there shown therein cross-sectionalviews taken along line B-B of FIG. 36, depicting two alternate slitconfigurations in accordance with preferred embodiments of theinvention. Slit 642 may have a substantially uniform slit width alongthe entire length thereof through septum 634. As an alternative, asillustrated in FIG. 41, the septum 642′ reduces in width as a taperedstep, so that the slit has its greatest width adjacent the septum upperportion 636′ and then in the distal septum portion 672′ there is astepped reduction in width of septum slit 642′, to a minimum width induckbill portion 643′. This stepped reduction in slit width allows awide luer taper to penetrate far enough to open the slit for fluid sflow into Y-site passage 620, while still sealing on the shaft of asmaller blunt cannula which completely penetrates the septum. As shown,the slit 642′ is preferably incomplete, having a residual membrane 671′which is ruptured when the slit 642′ is opened by insertion of the luertip.

FIG. 42 shows an alternate slit width reduction configuration in whichslit 642″ is tapered along approximately one half its length. As withthe embodiment of FIG. 41, the slit 642″ has its greatest width adjacentthe septum upper portion 636″ and then in extension 640″ there begins agradual reduction in width that continues through lower portion 672″, toa minimum width in duckbill portion 643″. This tapered reduction in slitwidth also allows a wide luer taper to penetrate far enough to open theslit for fluid flow into Y-site passage 620 while still sealing on theshaft of a smaller blunt cannula which completely penetrates the septum.Again, the slit 642″ is preferably initially incomplete as shown at671″.

By way of example, the Y-site base of the FIG. 26 embodiment may betransversely dimensioned so that the peripheral ledge 679 has a width ofabout 0.038-0.039 inches (0.965-0.991 mm) and so that the Y-site at theledge has a width of about 0.365 inches (9.271 mm) and a length of about0.508 inches (12.903 mm). The Y-site base 618 may be longitudinallydimensioned so that it has a main body length of about 1.305 inches(33.147 mm), whereas the side arm, which is angled at about 45 degrees,has a length of about 0.795 inches (20.193) from the longitudinal axisof the main body. The housing body portion 616 has an interiortransverse length at the distal end of about 0.442 inches (11.227 mm)and an interior transverse width of about 0.296 inches (7.518 mm).Finally, in this example, the septum distal portion 672 has a length ofabout 0.440 inches (11.176 mm), a width of about 0.294 inches (7.468mm), and a thickness of about 0.050 inches (1.27 mm).

Meanwhile, the interior height of the housing body portion 616 is about0.136 inches (3.454 mm), but the height above protrusions 671 is about0.0675 inches (1.715 mm), whereas the rim 673 of the Y-site has avertical dimension of about 0.025 inches (0.635 mm), thus leaving about0.0425 inches (1.080 mm) for the septum distal portion 672. It should beclear that these dimensions represent only presently preferred dimensionranges and other ranges can be employed or may be learned by practice ofthe invention.

Referring now to FIG. 43, there is shown therein an exploded perspectiveview of another embodiment of the luer receiver of the invention,incorporated in a Y-site. More particularly, referring to the views ofFIGS. 43-52, the luer receiver of this embodiment is constructed from atwo-part housing including an upper housing body 712 a and a housingbase 712 b. The upper housing body 712 a includes proximal portion 714and central portion 716. The housing base 712 b comprises the distalportion 718 which in the illustrated embodiment is configured as aY-site. The upper housing body 712 a and housing base 712 b have acomplementary shape for being operatively engaged, capturing the septum734 therebetween. Thus, in the illustrated configuration, the side wallsof the upper housing body 712 a define a bottom peripheral surface 777sized for engaging a complementary ledge 779 defined on housing base 712b.

Similar to the structure shown in FIGS. 4-16, projecting luer ears ortabs 727 are defined on housing proximal portion 714. Moreover, as inthe prior embodiments, housing recesses or cutouts 768 are also definedin the proximal portion 714 of the housing for allowing lateraldeflection of the walls of extension portion 740 at cutouts or recesses766.

As in the embodiments described above, septum 734 has an enlarged upperportion 736 for being seated on elevated portions 746 and troughportions 748 of the proximal portion 714 of the housing. Slots 754 aredefined between upper septum portion 736 and lower septum portion 738for allowing the upper septum 736 to deflect upwardly for being seatedon upper surfaces 756 of projections 750 along the platform elevations746. Grooves 752 for receiving projections are defined between the upperseptum portion 736 and projections 747, which are received in cutouts768 under projections 750

In this embodiment, a fluid seal is provided in the lower septum portion772 by centerless radial compression. More specifically, a fluid seal isprovided at duckbill 743 which is dependent on the radial compression ofthe septum without the septum having material in the center of thecompression. Instead, there is a hollow central region 783 in the septumlower portion 772. Rings 781 can advantageously be added to enhance theseal. This configuration has the advantage that as the fluid pressureincreases on the inside, the normal force the septum exerts on thehousing increases thus enhancing the seal.

By way of example, the Y-site base of the FIG. 43 embodiment may betransversely dimensioned so that the peripheral ledge 779 has a width ofabout 0.031 inches (0.787 mm) and so that the Y-site at the ledge has anouter peripheral radius of 0.21 inches (5.334 mm) and an innerperipheral radius of about 0.179 inches (4.547 mm). The Y-site base 718may be longitudinally dimensioned so that it has a main body length ofabout 0.892 inches (22.657 mm), whereas the side arm, which is angled atabout 45 degrees, has a length of about 0.712 inches(18.085 mm) from thelongitudinal axis of the main body. The housing body portion 716 has aninterior transverse diameter at the distal end of about 0.363 inches(9.22 mm). Finally, in this example, the septum distal portion 772 has adiameter of about 0.370 inches (9.398 mm) or about 0.400 inches (10.16mm) including rings 781, and a thickness of about 0.120 inches (3.048mm). It should be clear that these dimensions are given only by way ofexample and other ranges can be employed or may be learned by practiceof the invention.

The luer receiving valve of the instant invention is a robust valvecapable of preventing leakage despite high internal fluid pressuresadjacent the distal end of the septum. This leakage is prevented bothwith and without a penetrating luer tip in the slit. Leakage isprevented about the penetrating luer tip, in part by the relativelylarge mass of septum material juxtaposed with the penetrating luer tipdespite the limited space available for such septum mass. As discussedsupra, it is the unique matched configuration of the housing and septumwhich allows this higher juxtaposed septum mass to be accommodated andwhich allows a greater contact surface area between the septum and theside or shaft of the luer tip. In the preferred embodiment, upon fulladvancement of the luer tip into the septum, tight circumferentialcontact between the shaft and the septum is provided from the face ofthe septum to adjacent the tip so that sealing is greatly enhanced evenunder high back pressure situations such as a forced injection by amechanical injector. In the preferred embodiment this increased mass fordirect luer shaft contact is accommodated Within the confines of thesmall circumferential luer lock by the unique combination andconfiguration of spaces or cavities or displacement reservoirs forfocused displacement within the female luer lock when the luer tip isadvanced into the septum. As discussed, the displacement reservoirs orcavities can be defined by cutouts or slots along the valve, whichcutouts or slots can include portions of the housing or septum or acombination of septum and housing. These housing and septum cutouts orslots may be juxtaposed one with the other and also aligned with eachother to provide a wider reservoir for greater accommodation of septumdisplacement. In the preferred embodiment the reservoirs are isolatedfrom the slit and the fluid chamber and can be further isolated from thesurrounding atmosphere.

As noted supra the deflection reservoirs are preferably isolated andsealed from the fluid chamber distal to the septum so that thedisplacement volume shift induced by the inserted luer tip is directedaway from the fluid chamber. More specifically the displacement isdirected into the reservoirs and not into the distal fluid chamber orpathway so that the rebound of the septum back out of the reservoirsdoes not induce a negative fluid deflection within the fluid chamber. Inthe preferred embodiment, the tight seal is provided intermediate thereservoirs and the fluid chamber by the enlarged region below theextension, which seals circumferentially with the housing. The seal canbe provided by a compression seal with longitudinal compression and/ortransverse compression of the septum with the housing and can beprovided adjacent the distal end of the septum and/or adjacent the upperenlarged portion of the septum, if for example the reservoirs arecovered laterally. If preferred, a circumferential seal adjacent theupper portion can be provided by bonding for example the lower surfaceof the upper portion to the plateau of the housing or by providing acompression ring above the support which compresses the peripheral edgeof the upper septum portion between the ring and the circumferentialsupport.

A rigid floor, e.g. 76, 676, 776 can be provided adjacent the distal endof the septum which further prevents downward deflection of the distalend 72, 672, 772 of the septum 34, 634, 734 during luer tip insertion tofurther prevent the potential for rebound induced deflection of thedistal end of the septum away from the fluid chamber when the luer tipis withdrawn. The floor can have a small central opening for allowingfluid to pass through the floor upon tip advancement; the opening canfor example have a diameter equal to that of the flow channel of theluer tip, as shown by way of example in FIGS. 1A and 1C. Note that inthe luer receiver 10 a of FIG. 1A, the floor 76 a of the housing 12″defines an opening having a diameter equal to that of the flow channelof the luer tip. Since downward deflection of the septum 34 a isprevented or minimized as aforesaid, the lateral deflection reservoirs78 a of distal septum portion 72 a are sized to accommodate the materialof the septum distal portion deflected on luer insertion. The luerreceiver 10 c of FIG. 1C, is also configured so that the floor 76 c ofthe housing 12′″ defines an opening having a diameter equal to that ofthe flow channel of the luer tip. In this embodiment the floor 76 c isinclined so as to direct displaced material towards the lateraldeflection reservoirs 78 c on luer insertion, to prevent or minimizeseptum 34 c downward deflection. Again, the lateral deflectionreservoirs 78 c of distal septum portion 72 c are sized to accommodatethe material of the septum distal portion deflected on luer insertion.

The potential for rebound induced deflection of the distal end of theseptum away from the fluid chamber when the luer tip is withdrawn canalso be minimized by providing a distal duckbill valve sealing memberprojecting from the distal end of the septum. The duckbill valveminimizes negative fluid deflection since it opens and closes withminimal material displacement and precludes fluid counter flow upon luerwithdrawal. An exemplary duckbill valve structure is shown in the luerreceiver 10 b of FIG. 1B. In this example, the housing 12 is as shownand described with reference to FIG. 1. The distal end portion 72 b ofthe septum 34 b is modified, however, so as to define a duckbill valve43 that will project well beyond the tip of the inserted male luer. Thisprovides a one way (check) valve limiting the flow to a forwarddirection out of the luer tip and is only open in the presence of fluidpressure from the luer tip. As is apparent, the closure of the duckbillvalve upon cessation of fluid flow/pressure precludes fluid flowproximally into the slit of the septum 34 b upon luer tip withdrawal andminimizes the potential for rebound induced deflection of the distal endof the septum away from the fluid chamber, thereby reducing oreliminating the negative pressure associated with luer tip withdrawal.

The provision of lateral deflection reservoirs 78 aligned with the slitand the provision of a rigid floor 76 intermediate the septum and thefluid chamber are means to deflect or direct deflection of the septum ina direction away from the fluid chamber during luer tip penetration. Itis the combination of isolation of the septum extension from the fluidchamber and focused deflection of the septum away from the fluid chamberwhich achieves mitigation or elimination of the negative pressuredeflection upon withdrawal of the luer tip by preventing elasticdeflection of a portion of the septum into the fluid chamber uponadvancement of the luer tip.

The septum can be modified to achieve a positive pressure deflectionupon withdrawal of the luer tip by providing a portion of the septumwhich is interfaced with the fluid chamber and which is sized andconfigured to deflect away from or parallel with the flow chamber suchthat fluid enters a space adjacent the septum portion upon insertion ofthe luer tip and then forced back into the fluid chamber or flow channelupon withdrawal of the luer tip. The housing can be configured to divertthe lateral deflection of the septum portion into an upward directionand/or the septum portion can be configured to deflect and openlaterally adjacent the fluid interface. In one preferred embodiment,shown in FIGS. 53-55, a pair of slits 841 are provided in the distalportion of the septum 834 adjacent the fluid chamber. These are alignedto be perpendicular to the long transverse axis of the slit 842. Theslits extend only partially through the septum to define opposingelastomeric columns 839 on each side of and perpendicular to the centralslit. In one preferred embodiment the columns 839 are placed under acompression load by compression of the septum 834 against the adjoininglateral housing wall 812. This load is transmitted through the columns839 to the central slit 842 to more tightly seal the central slit. Theload is less than the threshold required to dilate the perpendicularslits 841. In the illustrated embodiment, to further maintain apre-penetration hermetic seal, the slit 842 is incomplete, leaving aresidual membrane 871.

When the luer tip 832 is advanced into the central slit, this places thecolumns 839 under a greater compressive load thereby deflecting open theperpendicular slits 841. Septum material is also deflected into lowercutouts or slots 878, as shown from a comparison of FIGS. 53 and 55.Substantially full insertion of the luer tip 832 ruptures membrane 871,if provided, while sealing ring 881, captured between housing parts 812a and 812 b, maintains a seal about the outer periphery of the septum834. As the perpendicular slits open during the luer insertion process,fluid will enter the cavities (FIG. 55) formed by the open slits 841.Upon withdrawal of the luer tip, the fluid will be forced back out ofthe cavities into the fluid chamber as they close. The perpendicularslits 841 can reduce the penetration force required to penetrate throughthe distal end of the septum by relieving the compressive force duringluer tip penetration. In this way a perpendicular compressive force canbe applied with a relief mechanism to allow both tight sealing bycompression but yet maintain a lower penetration force. Furthermore, theexpulsion of the fluid from the cavities upon luer removal reduces oreliminates the negative pressure typically associated with luer tipwithdrawal.

Due to the unique features and functionalities of the valve of thepresent invention, this valve provides superior infection prevention.Any portal to a patient represents a potential source of entry by theubiquitous bacteria in the environment. The first consideration of amedical valve positioned at a patient portal site should be itspotential to harm the patient by allowing bacterial ingress. Any valvedesign for access to a patient should be thoughtfully consideredrelevant its inherent potential (or the limitation thereof) to reducebacterial ingress at the portal site. Only if the valve does not pose anincreased threat to the patient should its safety to healthcare workersbe considered an advantage and the ideal valve should reduce the threatwhen compared with the gold standard traditional reseals which have beenused for over two decades. Yet healthcare worker safety has been therecent focus of proposed legislation in California and elsewhere, in therush to enhance the safety of healthcare workers the potential risk thatmore complex piston valves pose to certain vulnerable patient groups hasbeen overlooked.

There is growing evidence that, while the new needle-less IV accesssystems in general are safer for the health care worker, they may beassociated with an increase risk for the patient, especially a patientwith a weak immune system, such as for example a breast cancer patientwho has received chemotherapy or a bone marrow transplant. Since thesepatients have a low white blood cell count for defense against bacteriathey are vulnerable to even low numbers of bacteria which may beintroduced into the body through an artificial portal such as a IVaccess site. This is also true of transplant patients or patients withleaking heart valves or indwelling prosthetic valves or devices. Inthese patients, even a few bacteria introduced into the bloodstream cancolonize the valve or device because the patient's defenses are not veryactive at the site of the artificial prosthesis or leaking valve. Theseimportant microbiologic considerations have been largely overlooked inthe rush to make the transition from traditional IV systems which usedneedle penetration of elastomeric septa for access to the moremechanically complex, piston based needle-less systems widely used inthe present art. The old traditional reseal systems were simple septafor receiving a sterile needle, they lacking moving parts and could beeasily prepped over their entire upper face. The process wasmechanically simple and similar to penetrating a needle into preppedskin. These simple reseals had no exposed internal pistoning parts whichcould be colonized about the exterior boundary of the bore of thehousing as is present with several conventional luer access devices.

The present invention serves to overcome the problems of increased riskof patient infection while still providing complete protection for thehealthcare worker. It is the purpose of the present invention to providean enhanced barrier to prevent bacteriologic ingress and invasion at apatient access portal such as an IV terminal. The present inventor usesthe term Patient Protection Portal “PPP” to emphasize that the presentinvention is designed to achieve enhanced barrier protection for thepatient as well as providing healthcare worker safety.

One important mechanism to prevent bacterial ingress is the provision ofa tightly sealed slit. The present invention provides sealing atplurality of levels of the slit and preferably provides compression toinduce sealing of the slit along at least two levels of the slit. Thepresent invention further provides a tight seal between the septum andthe flow channel. Preferably this seal seals the outer perimeter of theextension against migration of fluid or air into or out of the fluidchamber about the outer perimeter. This seal can be provided bycompression between the housing and the septum. The compression ispreferably provided circumferentially about the housing. In this way theflow chamber is sealed from the outside environment at three levels, theupper face, the lower interface with the fluid chamber and about theperimeter of the septum. In one preferred embodiment a fourth area ofsealing is provided immediately below the upper surface of the septum byfocused compression below the “wedged closed” slit -surface interface.Further in one presently preferred embodiment a fifth sealing point isincluded with the addition of a duckbill valve at the end of the septum.

The enhanced sealing afforded by the high contact mass allows the valveto be incorporated into a wide range of medical devices wherein leakageabout the shaft associated with a high back pressure or a high internalvacuum is prevented by the higher mass of the contacting septum as wellas the higher contacting surface area of the septum along the slit whichis facilitated by the long length of the slit. These devices include,for example, vacuum filled blood collectors, high pressure injectionsystems such as those used for contrast injection during radiographicprocedures including angiography, and drug vials. It is highly desirableto provide luer lock access to hermetically sealed drug vials. However,while drug vials do not normally have a high resting internal pressure,the injection of diluent into a closed vial can be associated with thedevelopment of markedly high back pressures and leakage around the shaftand associated aerosolization of drug must be prevented during such amaneuver by tight sealing about the shaft of the indwelling luer tip.

As noted supra, this valve is intended for universal use. For thispurpose the valve can be constructed as a cap with an upper housingportion, such as upper housing portion 612 a, described with referenceto FIGS. 26-40, containing the septum, e.g. 634, mounted on the proximalend of an open or closed chamber for storing or flowing fluid.Alternatively the septum can be inserted into an integral housing whichincludes both the upper housing which holds the septum and the lowerhousing which comprises the flow channel or fluid chamber. FIGS. 56-59show examples to the adaptability of the invention to various containersand flow systems. In some environments, such as mounting on a blood tube603 (such as a hemodialysis blood tube), the cap portion 612 acontaining the septum 634 is all that is required with the blood tube603 providing the lower chamber or flow channel. A similar configurationcan be seen with an IV bag 601 where the cap 612 a, 634 is mounted tothe bag for luer access to the bag comprising the fluid chamber.

FIG. 59 shows a blood or specimen collector 604 designed to receive asharp needle, blunt cannula, luer slip connector, or luer lockconnector. The container is preferably comprised of shatterproof plasticas is known in the art. The collector includes a luer-receiving valve,which defines a container cap, for example of the type provided by upperhousing portion 612 a and septum 634. The cap thus includes a housing612 a, which is preferably rigid, and an elastomeric portion 634 havinga central slit mounted with the housing. The cap further includes anupper surface adjacent the proximal end and a distal end. The cap issized to be bonded adjacent the open distal end of the receptacle and toocclude the distal end of the receptacle.

The diameters of many conventional adult blood collection containers arelarger than that of conventional female luer lock end. For this reasonthe receptacle can have a reduced diameter at the proximal open end ofthe receptacle. Alternatively the housing of the cap may be adapted toprovide a larger internal or outside diameter to engage the largerdiameter adult tubes. The cap may be joined with the collection tube byintussusepting one of the cap and the open distal end of the receptacleinto the other or by otherwise mounting the cap adjacent the distal end.A compression seal may be provided about the open proximal end of theblood collecting tube and the septum portion of the cap. It ispreferable to minimize cost to have a single mold for septa which can beused for capping vacuum filled containers, drug vials, Y-sites, salinewells, catheter terminals, stopcocks, manifolds, intrauterine andintracranial pressure monitoring devices, and blood tubing ports. Thiscan be achieved by using a single configuration for the upper portion ofthe housing adjacent the septum. The many diverse housing and flowchannel structure below the septum can be adapted to accommodate andseal with the septum in the cap. In this way hospital personnel willalways see a standard connection terminal, and will understand itsfunction, and compatibilities. Also the process of designing and testingmany different new molded configurations of septa for differentapplications is avoided. Indeed a breakaway membrane discussed supra,can be included as part of the standard septum design.

In operation the luer tip is inserted through the slit into thereceptacle. The specimen is transferred into the receptacle and the luertip is withdrawn, the septum automatically seals upon withdrawal of theluer tip.

It is advantageous for any standard receptacle used to collect blood,whether a rigid tube or flexible bag to have an interface for a luerlock connector. This is because blood is often initially collected fromcatheters using a syringe. If the syringe uses a luer slip, the tip canslip out of the catheter terminal potentially resulting in a blood spillpotentially exposing the nurse or physician to blood. This isparticularly true because the nurse or physician is pulling back on theplunger of a syringe to collect the blood. This pull can cause the luerslip to pop out. If the connection is arterial, as with a left heartcatheter, blood can spurt out if the luer slip comes out of theterminal. In addition to aforementioned problems on the initialcollection side, the luer slip also does not allow for optimal alignmentof the luer slip with the collection container itself and the luer slipis also vulnerable to slipping out of the blood collection container. Inaddition, luer slip syringes are not in wide use in many parts of thehospital and therefore may not be readily available for blood collectionas in an emergency. It is the elimination of incompatibility, which isone of the purposes of the present invention. For these reasons, theblood collector of the present invention allows for compatibility withluer lock connector, luer slip connectors, blunt cannulae, and sharpneedles. It is intended that this functionality be universally availablefor virtually all connections or interfaces in the hospital environment.

When the valve is incorporated into vacuum filled containers 604 orother closed receptacles, e.g. a drug vial 602, which contain apharmaceutical, diluent, or IV solution for example, the septum must behermetically sealed for long term storage as by an unperforatedmembranous seal adjacent a portion of the slit. It is preferable thatthis seal be homogenous with the septum so that expense can beminimized. In one preferred embodiment discussed supra this was providedby assuring that the central slit was an incomplete slit, the slitextending only partway through the septum to a point adjacent one end ofthe septum (See reference numeral 71 in FIG. 1). A sharp projection,which may be mounted with the housing, can be provided to cut orotherwise disrupt the membrane to open the passage to the receptaclethrough the slit. Alternatively the septum and membrane can beconfigured such that the membrane tears open with a low penetrationforce so that even a blunt luer tip easily separates the hermetic sealso that the expense and molding considerations associated with a sharpdisruption projection are not required. One method of achieving thisincludes the application of a thin elastomeric plug or coating to theseptum, as to the upper septum surface, which is penetrated on the firstpenetration by the luer tip, as described below with reference to FIGS.64 and 65. This plug can be comprised of silicone have a low tearresistance (as is known in the art) and easily torn. The plug can beslightly slitted at its upper or lower surface to facilitate tearingupon stretching of the plug.

Since the luer tip is very blunt, the large diameter of the tip wouldnormally be seen as a disadvantage making the penetration force thoughan unperformed membranous seal more difficult. For this reason thepresent invention achieves the feature of tearing with a low penetrationforce by actually exploiting the relatively large diameter of the luertip to achieve mechanical advantage for membrane tearing. Morespecifically, the present invention uses the large diameter of the luertip in combination with strategically placed septum cutouts and orslits, to maximally spread apart the elastomer in a focused regionadjacent a weakened portion of the membrane so that the seal will tearopen. To facilitate this the elastomeric membrane across the slit ispositioned along the slit such that the luer tip engages or transmitssubstantial stress to a specific region of the membrane. Usingstrategically placed cutouts is one means to predetermine the region towhich the stress is focused since, as discussed supra, they can definethe region of the septum, which is maximally stretched by deflectioninto the cutouts. By weakening a portion of this region ease of forcefuldisruption upon luer advancement is optimized and the stretching of themembrane and its disruption can be focused to a small region to minimizethe penetration force required to achieve disruption. In one embodimentthe slit terminates in an oblique membranous seal which can be formed byslitting the septum to a point adjacent the end of the septum whereinthe septum distal end provides a parallel oblique projection. The shortmembranous segment remains unslitted and provides a hermetic seal. Theslit therefore ends in a blind pouch obliquely oriented with respect tothe face wherein the configuration of the end of the pouch is such thatthe luer tip engages the upper portion of the sealing membrane andstretches the upper end until it tears. The tear is then continued alongthe oblique membrane as the luer tip is further advanced. Additionalweakening slits extending partially into the septum adjacent themembrane can be provided (as described above with reference to FIGS.53-54) to additionally weaken the membrane against transversestretching.

For both the penetration and activation designs the configurationsdiscussed supra eliminate deadspace. This is most important if the valveis intended for bi-directional flow wherein blood withdrawal through thevalve is a desired function or wherein blood or plasma is to beadministered through the valve. Blood, because of its viscosity and theadherent properties of the fibrin, plasma proteins and red blood cellshas the potential of sticking within deadspace and may be difficult towash from these areas. Also, when used with blood conserving arteriallines or with hemodialysis lines for blood withdrawal it is importantnot to have any deadspace within the valve structure flow path orbetween the valve structure and the flow channel of the line since thiswill require the withdrawal of a prior discard sample before withdrawalof a blood sample for testing. As in the present invention, thelimitation of flow to the central flow path and/or the provision ofdeadspace displacement material within any resting deadspace whichinterfaces with medical fluid during operation, addresses these issues.

If preferred other features can be added to enhance functionality. Afeature which can be included is the provision of an incomplete slit atdistal end of the septum (as providing a residual membranous closure 71across the slit 42 where it would otherwise directly contact the flowchannel 20 in the embodiment of FIG. 1 ). This allows the device to beused in situations wherein absolute sealed closure must be maintainedprior to first penetration. To provide ease of disruption of themembrane it may be weakened in an axis parallel to the slit or a sharpmember may be provided adjacent the membrane which contacts the membraneupon downward deflection of the septum.

FIGS. 60-63 show a luer receiving valve embodiment intended for lueractivation of the valve mechanism induced by downward deflection of aseptum and the application of a compressive force against at least onewall of a septum to open a central perforation or slit through theseptum rather than by luer tip penetration into the septum as shown inthe previous embodiments. The use of compressive force and contactmembers to open a central slit through a septum is discussed in U.S.Pat. Nos. 5,549,651 and 5,697,915 (the disclosures of both of thesepatents are included herein by this reference as if completely disclosedherein) which provide background for the present invention. As disclosedin the aforementioned patents the slit can be aligned centrally withinthe septum and the application of compression against the wall of anelastomeric septum wall can include compression against an internalseptum wall, which will deflect the opposing walls of the slit apartalong the same axis as the compressive force. Alternatively compressioncan be applied against an external wall which will deflect the opposingwalls of the slit apart in an axis perpendicular or oblique to the axisof the compressive force. Generally, FIG. 60 shows a luer receiverwherein the septum is pressed against a contact member by forcefulpressure of the male luer tip against the outer face of the septum. Theseptum is thereby squeezed such that compressive force is appliedagainst the septum from two opposing directions both applying acompressive force along the longitudinal axis of the septum to deflectthe slit into an open position along its entire length.

The luer receiver 910 includes housing 912 and an elastomeric septum 934with an elastomeric distal extension 940 mounted within the housing 912.The housing includes an outlet 922 and a main cylindrical bore 926. Theseptum 934 includes a cylindrical portion 936 sized to slideably advancealong and seal about the main bore 926. The septum 934 includes a slit942 and an outer face 960 with opposing elevations 958 aligned with thelong axis of slit 942. Opposing flexion recesses 954 are providedparallel to the long transverse axis of the slit, which allow the face960 to flex upon forceful contact as will be discussed. The recesses 954and indeed other portions of the receiver 910 intermediate the housing912 and the extension 940 may be filled with a deadspace filler (notshown) with a high resting volume but a low compressed volume (such asmedical foam rubber) to eliminate any resting deadspace within thehousing 912. The slit 942 defines opposing internal walls 921 and 923which are closed when the septum is mounted in its resting position withthe outer face 960 positioned adjacent the proximal end 914 of thehousing 912. The slit 942 exits the side of extension 940 surrounded bygasket 981, which is sized to be sealingly received in flow, channelwall 916. The slit 942 exits at the side of extension 940 into the flowchannel 937. The slit 942 divides the extension 940 into sides 939 and941 which alternatively can be thinned laterally (for example to defineconcave outer walls as for the extension of FIG. 1) to provide easierlateral deflection and reduced resistance to compression. Thinner wallscan, for example, be used when a higher durometer (such as 40) siliconeis used in manufacture. The luer receiver 910 includes distal contactmembers 943 at the end of the bore 926 and projecting toward the bore926. In operation, as the luer tip 932 (FIG. 60) is pressed against theface 960 of the septum 934, the elevations 958 are pushed downwarddeflecting the face 960 of septum 934 to a greater extent parallel tothe long axis of the slit 934 than perpendicular to said axis therebyflexing the face and biasing the upper portion of the walls 921 and 923apart to open the slit 942 adjacent the face 960. The distal contactmember 943 is positioned such that when the male luer 932 advances theseptum 934 along the bore 926 against the distal contact member 943, thedistal contact member 943 deflects the lower portion of the walls 921and 923 apart such that the slit is opened along its entire length. Theseptum 934 is relatively soft and elastic and can be of elastic siliconehaving a durometer of about 20-40 so that the septum will easilycompress against the distal contact member 943 but will rebound afterbeing released. The order of closing along the slit 942 is reversedrelative to the order of opening when the septum 942 rebounds to itsproximal resting position so that the proximal portion closes first whenthe pressure is removed from the elevations 958. Thereby deflecting anyresidual fluid in the slit 942 toward the flow channel 637 to mitigateand indeed eliminate negative fluid pressure deflection within the flowchannel 937 upon rebound of the septum 934. It can be seen that the slit942 opens to the side of septum extension 940. This allows for deadspace free mounting access in a side arm configuration as shown in FIG.63 with the slit 942 exiting the side of the extension 940 directly intothe flow channel 947 of tube 949.

FIG. 64 shows a modification of the gasket 981 shown in FIG. 62 toprovide an extended gasket molded as an integral elastomeric tube 951molded with the side of extension 953, the port exiting into the tube951. This tube 951 is intended for intussuseption and sealing with aflow channel housing 949 of the type shown in FIG. 63 (not shown in FIG.64) and can be encased with or otherwise surrounded by the flow channelhousing 916. If preferred a rigid coupling, not shown, can be used tosecure with the tube 951 at both ends. If the tube is encased within anouter tube, the encasement can for example be comprised of rigidpolycarbonate or similar plastic, which is integral with a septumhousing, e.g., 912. With the embodiment shown in FIG. 64 the slit 942′extends directly from the atmospheric face of the elastomeric septum tothe side mounted flow channel within the integral elastomeric tube 951thereby passing through and being completely enclosed and sealed withina single molded elastomeric structure thereby providing simplifiedmanufacture. With this embodiment, a short neck 957 can be provided toproject the exit port 959 and its enclosed slit 942′ laterally toward aslightly more laterally positioned tube 951 and compression can beapplied to the neck perpendicular to the slit 942′ to distally seal theslit 942′ in the neck when the luer tip is not advanced against theseptum. This embodiment may be modified to achieve opening adjacent theatmospheric interface during advancement of the septum by the use ofopposing laterally projection cams as shown for the preferred embodimentof U.S. Pat. No. 5,549,651 in the place of the mechanism of downwardfacial flexion discussed supra.

Although not shown, a similar side mounted gasket or sealing tubeconfiguration can be used with the luer penetration receiver to providedeadspace free side arm mounting of the septum with a simplified onepiece silicone septum-tube configuration. With this type of design theport can be a lateral projection of the extension of the type shown inFIG. 1. The port preferably projects about the slit and extends in anaxis perpendicular to the cutouts of the extension. The slit narrowsdistally to limit the distal advancement to the luer to a point justabove or adjacent the port so that upon advancement of the luer tip theluer tip remains vertical but the nascent open flow path which is wedgedopen by the luer tip turns to an obliquely or perpendicularly positionedopen port. With such a design the neck (if provided) is preferably onlya few millimeters or less in length so that the slit extending throughthe port is wedged open into the flow channel when the luer tip isadvanced into the extension. The rigid housing can be simply the housingabout the upper portion and extension of the septum as shown in FIG. 1but wherein the housing ends distally with a circumferential or nearlycircumferential mounting about the neck adjacent the port. Alternativelythe housing can be joined with or be molded with a casing of the typediscussed supra mounted about the side mounted tube. The housing, whichcan include slots as shown in FIG. 1, can be mounted to the entire onepiece receiver which includes the silicone tubing and septum structureto provide rigidity for threading the luer lock about the proximal endof the septum and to provide focal compression in narrow regions (forexample regions having a length of 1-3 mm.) adjacent the proximal endand adjacent the neck. Adjacent both compression regions, the housingand the receiver are sized and configured to provide compression in avector perpendicular to the slit as it extends from the atmosphericinterface to exit laterally at the port projecting from the extensioninto the integral tube.

FIGS. 65 and 66 show, as a further embodiment of the invention, a bloodcollector and septum structures for use with a male luer. The collectorhas an open ended housing 1012 and a septum 1034 mounted with thehousing 1012 and occluding the housing. The housing contents arepreferably under vacuum, maintained by the sealing septum. Lateralcutouts 1066, 1066′ are provided to focus the deflection of the septum.An elastomeric plug 1000, 1000′, such as a silicone plug having a lowtear resistance, is provided adjacent at least one end of the slit 1042,1042′.

In the embodiment of FIG. 65, the slit 1042 is made after the plug 1000has been bonded to the septum 1034. In the embodiment of FIG. 66, theseptum 1034′ is slitted (or molded with a preformed slit) and then theplug 1000′ is bonded thereto and a second slit 1142 is made in the plugat the surface, to facilitate subsequent luer penetration. If preferred,the septum and plug can be initially molded together as a single unit oftwo silicone members and then slitted or they can be molded with theslits in place as desired. It is preferable that the septum have a hightear resistance as is conventional for the septa of blood collectors.The plug on the other hand is preferably comprised of silicone with alow tear resistance so that the partial slit through the plug is easilyextended through the plug by the splitting effect of the large diametermale luer tip.

The medical valve of the instant invention can be applied to achieve aminimal dead space configuration at both the upper atmospheric surfaceand the fluid interface. This allows blood sampling without thecollection of blood within the fluid chamber below the septum. Anembodiment of a luer receiver 1210 integrated with a minimal deadspacestopcock 1207 is shown by way of example in FIG. 67. The stopcock 1207has a ramped flow channel 1237 provided within the central rotatingmember 1208 of the stopcock below the septum 1234 to further allow easeof displacement of any residual blood from below the septum. Anotherembodiment, shown in FIG. 68 includes a plurality of valves 1210′mounted on the stopcock 1207′.

The present invention further allows the application of a universalsafety feature for medical connection. The disconnection of medicaldevices represents an inherent risk to patients in the presentconventional art, and the FDA has identified this risk. The FDArecommends checking connections for security but regrettably the luerlock connection, despite its name, is a simple threaded connection withthe inherent potential for unwanted disconnection at any time. Suchunintentional disconnection can result in bleeding, air embolism, etc.which can be silent (as when the patient is sleeping) and can result indeath. The present invention, by its universal applicability andfunctionality and further as a function of its inherently lowmanufacturing cost, makes possible a new standard of patient luerconnection, whereby any proximal terminal of a tubing system or catheterwould be closed by an integrally attached “valve” defined by a luerreceiver. The integration of the luer receiver/valve of the presentinvention into the terminal of catheters further eliminates thepotential that unwanted disconnection can occur at the catheter site(one of the more common disconnect sites). This provides for thecomplete elimination of the potential for disconnect-related morbidityand death. The new standard will be “NO OPEN DISCONNECT”. This is amatter of safety for both healthcare workers as well as patients sinceany bleeding through a disconnect creates an OSHA “blood-spill” whichrepresents a threat to the laundry service, housekeeping, and to thenurses or physicians correcting the matter. FIG. 69 shows a catheter1312 with an integral luer receiver 1310 at the proximal terminal and asecond luer receiver 1310′ for piggyback connection extending from oneside. FIG. 70 shows a safe “no open disconnect” IV tubing system 1412having a luer receiver 1410 provided in accordance with the invention atthe proximal end, and a luer lock end 1418 at the distal end. Thissystem is designed to assure that any inadvertent disconnect does notpose an open communication risk to the patient.

Referring to FIG. 71, the luer access container 3010 includes areceptacle 3020, which is comprised of glass or shatterproof plastic,having an open end 3024 and projections 3026 for engaging a stopper 3030within the open end 3024. A retainer 3034, which is preferably of metalor rigid plastic, is provided to hold the stopper 3030 in place. Theretainer 3034 includes a luer receiver 3036 with lugs 3040 for receivingthe threaded luer lock member 3044. Alternatively threads can beprovided. The stopper 3030 includes an upper face 3050 for receiving theluer tip 3054, a central downward projection 3056, and a lower portion3060 for engaging the wall 3064 of the receptacle 3020 adjacent the openend 3024. A slit 3070 is provided extending partially through thestopper 3030. The retainer 3034 includes downward projecting edges 3074that fit into a circumferential slot 3080 about the face 3050. The edges3074 can be swaged onto the stopper face 3050 to hold the face 3050tightly in place. The slit 3070 ends in a membranous cover 3085 at theface.

FIGS. 72, 74 and 75 show a membrane perforating cap 3086 for perforatingthe membrane 3085. The cap 3086 includes a handle 3087 and recessedthreads 3088 sized to be received over the luer receiver. The cap 3086provides a smooth circumferential wall 3088 a distal the recessedthreads 3088 to allow the cap 3086 to fit over the receiver 3036 withoutthreading. The recessed threads 3088 are sized to be received about lugs3040 during threading immediately prior to use as will be discussed. Thecap 3086 includes a projecting sharp spike 3089. The spike 3089 isrecessed within the cap 3086 so as to be inaccessible to human fingersand so that it does not engage the membrane 3085 prior to threading. Therecessed threads 3088 serve as a stop upon contact with lugs 3040 sothat the spike 3089 does not penetrate the membrane 3085 when the cap isinitially mounted on the receiver 3035. During manufacture, the cap 3086is placed over the receiver 3036 partially threaded onto the lugs 3040of the luer receiver 3036 to a position wherein the spike 3089 has notyet engaged and/or penetrated the membrane 3085.

An outer fixation shrink-wrap (not shown) is then applied to cover cap3086, retainer 3034 to both bond and seal the cap member 3086 in thisposition with the spike 3089 above the membrane 3085 so that the cap3086 is sealed and cannot be further advanced about the receiver 3036and so that the membrane 3085 cannot be penetrated inadvertently. Ifpreferred, a stop (not shown) can be provided below the cap 3086adjacent the receiver 3036 during manufacture to limit advancement ofthe cap 3086 during manufacture. The stop is particularly useful if arecessed blade (such as a sharp angled blade having for example theconfiguration of a #11 surgical blade which can be mounted in alignmentwith the slit), is provided instead of a spike since such a blade wouldbe preferably advanced by direct digital pressure against the cap ratherthan threading.

During operation, the wrap is removed and the cap member 3086 is rotatedto advance the cap member 3086 over the luer receiver 3036 so that thespike 3089 perforates the membrane 3085. The cap 3086 is then rotatedoff the receiver 3036 and discarded after the membrane 3085 has beenperforated. The luer receiver 3036 is now ready to receive aconventional luer tip 3054, which more easily penetrates the nowperforated membrane 3085.

In an alternative embodiment (shown in FIG. 73) which can be used withor without a membrane-perforating cap, the stopper 3090 is recessed toreceive the conventional luer lock housing 3044. An upper slit 3100 isprovided which is separated from a lower slit 3110 by a membrane 3120,which can be directly transverse or can be obliquely oriented as in FIG.73. This configuration provides a greater mechanical advantage for theluer tip 3054 (see FIG. 71). As the luer tip 3054 advances it stretchesthe upper step portion 3130 of the membrane 3120 transverse to the slit3100 to a greater extent at the upper membrane portion 3130, since theamount of transverse membrane stretched is less with this configurationthe penetration force required to engage the membrane is less. Furtherthe stress is focused on a singe narrow upper portion 3130 so thatrupture requires less cumulative threading force. Alternatively, themembrane can have a directly oblique orientation without having an uppertransverse step portion.

In both the embodiments, if preferred, the stopper can be covered andsealed by an external outer sealing shrink-wrap as is well known in theart and widely used for drug vials. Also the slit can be made to extendall of the way through the stopper if preferred. As an alternative tothe separate cutting cap, a metal spike or sharp member can provided asintegral with the retainer projecting inwardly toward the top membranefrom the metal retainer. Such a cutting member can be forced into themembrane by the luer tip or by otherwise pushing against cutting memberto provide perforation prior to or during luer entry into the face ofthe stopper.

Many modifications may be made within the scope of this teaching. Forexample opposing slots for receiving the lugs may be provided in themembrane-perforating cap to align a recessed blade with the slit. Also,the cap may be integrally molded with a cover over the end of the vialwith a tear tab and circumferential weakening ring about the cap whichextends below the cap functions as a stop and which upon removal allowsadvancement of the cap.

In operation the nurse removes the shrink-wrap and/or tears away thestop and then directly advances or threads the cap over the receiveruntil the membrane the spike or blade penetrates or cuts the membrane inalignment with the slit. The cap is then removed and discarded and thenurse threads a luer lock connector onto the receiver until the luer tippenetrates to sufficient depth into the slit to provide a flow pathbetween the lumen through the luer tip and interior chamber of the drugvial. The septum now functions to provide a tight seal about the luertip preventing leakage during both pressurization and aspiration of orfrom the chamber. The receiver seals after luer tip removal and thenfunctions to provide multiple accesses of the vial chamber withconventional luer lock receivers.

Although the presently preferred embodiments have been described, itwill be obvious to those skilled in the art that various changes andmodifications can be made without departing from the invention. Thus,while the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

1. A luer receiving valve for receiving a male luer mounted within athreadable luer lock connector shroud into fluid communication with aflow channel, the valve comprising: a luer valve housing having an inletand a proximal portion sized to be received into the luer lock connectoradjacent the inlet, the housing having a channel for fluid passage and aseptum positioned within the channel, the septum defining a proximalportion, a distal portion, and a resealable slit configured to allowinsertion and penetration of the male luer into the slit; and a flooradjacent the septum, the floor being configured to prevent deflection ofthe septum into the flow channel when the male luer is inserted into theslit and into fluid communication with the flow channel.
 2. The luerreceiver of claim 1, wherein the floor includes a flow path extendingthrough the floor, the slit being positioned proximal of the flow pathso that when the slit opens, fluid from the slit can flow into the flowpath.
 3. The luer receiver of claim 1, wherein the floor extendslaterally, proximal the flow channel to deflect the septum away from theflow channel.
 4. The luer receiver of claim 1, wherein the floor slopesdistally to deflect the septum away from the flow channel.
 5. The luerreceiver of claim 1, wherein the septum is displaced laterally along thefloor when the male luer is inserted into the slit.
 6. The luer receiverof claim 1, wherein the septum is displaced laterally and downwardlyalong the floor when the male luer is inserted into the slit.
 7. Amethod for mitigating negative pressure within a flow channel of a luerreceiving valve during the withdrawal of a male luer from the valve, thevalve comprising a luer valve housing having an inlet and a housingproximal portion adjacent the inlet, a septum having a septum proximalportion within the housing proximal portion and a resealable slit formedin the septum proximal portion, and a flow channel distal of saidresealable slit, the method comprising: inserting a male luer mountedwithin a threadable luer lock connector shroud into the septum throughat least a portion of the resealable slit; receiving the housingproximal portion into said threadable luer lock connector housing, alongwith the septum proximal portion; and restraining the septum againstdeflection into the distal flow channel when the male luer has beeninserted into the septum through said at least a portion of the slit andplaced in fluid communication with the flow channel.
 8. A luer receivingvalve for receiving a male luer mounted within of a threadable luer lockconnector shroud defining a distal end, the valve comprising: a luervalve housing having an inlet and a proximal portion sized to bereceived into the luer lock connector adjacent the inlet, the housinghaving a channel for fluid passage; and a septum positioned within thechannel, the septum defining a proximal portion, a distal portion, and aresealable slit configured to allow insertion and penetration of themale luer into the slit; wherein, the septum comprises a distallyprojecting extension extending distally from the proximal portion to thedistal portion, the extension defining opposing walls on opposing sidesof the slit, the opposing walls being of lesser transverse dimensionperpendicular to the slit than the transverse dimension of the proximalportion perpendicular to the slit; and wherein the housing definesopposing internal walls lateral to the opposing walls of the extension,the septum being displaced laterally toward the opposing internal wallsof the housing by the penetrating insertion of the male luer into theslit; said valve further comprising: a flow channel distal of at least aportion of the septum for receiving flowing liquid from the male luerwhen the luer has been inserted into the septum; and a floor adjacentthe septum, the floor being configured to prevent deflection of theseptum into the flow channel when the luer is inserted into the slitinto fluid communication with the flow channel.